GENERAL INSTRUCTIONS - FOR FORM FDA 

3500A MEDWATCH (FOR MANDATORY

REPORTING)
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Table of Contents

FRONT PAGE....................................................................................................................................................................................... 6

SECTIONA: PATIENT INFORMATION ...................................................................................................................................................... 8

A1: Patient identifier.......................................................................................................................................................................... 8

A2: Age or Date of Birth...................................................................................................................................................................... 8

A3: Sex/Gender.................................................................................................................................................................................. 8

A4: Weight......................................................................................................................................................................................... 8

A5: Ethnicity....................................................................................................................................................................................... 9

A6: Race ............................................................................................................................................................................................. 9

SECTION B: ADVERSE EVENT OR PRODUCT PROBLEM......................................................................................................................... 10

B1: Type of Report............................................................................................................................................................................ 10

B2: Outcomes attributed to adverse event...................................................................................................................................... 10

B3: Date of Event ............................................................................................................................................................................. 11

B4: Date of this Report..................................................................................................................................................................... 12

B5: Describe Event or Problem......................................................................................................................................................... 12

B6: Relevant Test/Laboratory Data, Including Dates........................................................................................................................ 12

B7: Other Relevant History, Including Preexisting Medical Conditions:............................................................................................ 13

SECTIONC: SUSPECT PRODUCT(S)........................................................................................................................................................ 14

C1: Name, Strength, Manufacturer/Compounder ........................................................................................................................... 14

C2: List Medical Products and Treatment Given at the Same time of the Event and Date ............................................................... 14

C3: Dose, Frequency & Route Used.................................................................................................................................................. 14

C4: Treatment/Therapy/Usage Start and Stop Dates....................................................................................................................... 15

C5: Diagnosisfor Use........................................................................................................................................................................ 15

C6: Product Type.............................................................................................................................................................................. 15

C7: Expiration date........................................................................................................................................................................... 15

C8: Event Abated AfterUse Stopped or Dose Reduced .................................................................................................................... 15

C9: Event Reappeared After Reintroduction .................................................................................................................................... 15

SECTION D: SUSPECT MEDICAL DEVICE ............................................................................................................................................... 16

D1: Brand Name............................................................................................................................................................................... 16

D2a: Common Device Name ............................................................................................................................................................ 16

GENERAL INSTRUCTIONS - For Form FDA 3500A MedWatch (for Mandatory reporting)
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D2b: Procode ................................................................................................................................................................................... 16

D3: Manufacturer Name, City and State .......................................................................................................................................... 16

D4: Model #, Catalog #, Serial #, Lot #, Expiration date, Unique Device Identifier (UDI) # ............................................................... 16

D5: Operator of Device .................................................................................................................................................................... 17

D6a: If Implanted, Give Date............................................................................................................................................................ 17

D6b: If Explanted, Give Date ............................................................................................................................................................ 17

D7a: Isthis a Single-use Device that was Reprocessed and Reused on a Patient? ........................................................................... 17

D7b: If yes, Enter Name andAddress of Reprocessor....................................................................................................................... 17

D8: Is this device everserviced by a Third Party? ............................................................................................................................ 17

D9: Isthis Device Available for Evaluation?...................................................................................................................................... 17

D10: Concomitant Medical Products and Therapy Dates ................................................................................................................. 17

SECTION E: INITIAL REPORTER ............................................................................................................................................................. 18

E1: Name and Address..................................................................................................................................................................... 18

E2: Health Professional .................................................................................................................................................................... 18

E3: Occupation................................................................................................................................................................................. 18

E4: Initial Reporter Also Sent Report to FDA.................................................................................................................................... 18

SECTION F: FOR USE BY USER FACILITY(UF)/IMPORTER – DEVICES ONLY............................................................................................ 19

F1: Check one................................................................................................................................................................................... 19

F2: User Facility/Importer Report Number ...................................................................................................................................... 19

F3: User Facility or Importer Name/Address.................................................................................................................................... 19

F4: Contact Person........................................................................................................................................................................... 19

F5: Phone Number........................................................................................................................................................................... 19

F6: Date User Facility orImporter Became Aware of Event.............................................................................................................. 19

F7: Type of Report............................................................................................................................................................................ 19

F8: Date of this Report..................................................................................................................................................................... 19

F9: Approximate Age of Device ........................................................................................................................................................ 19

F10: Adverse Event Problem ............................................................................................................................................................ 20

F11: Report Sent to FDA? ................................................................................................................................................................. 20

F12: Location Where Event Occurred .............................................................................................................................................. 20

F13: Report Sent to Manufacturer? ................................................................................................................................................. 20

F14: ManufacturerName/Address................................................................................................................................................... 20

SECTION G: ALL MANUFACTURERS AND RESPONSIBLE PERSONS........................................................................................................... 21

G1: Contact Office ........................................................................................................................................................................... 21

G2: Report Source............................................................................................................................................................................ 21
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G3: Date received by manufacturer or responsible person............................................................................................................. 22

G4: This block is for use by all manufacturers of drug, device, biological products......................................................................... 22

G5: Give IND/Pre ANDA Protocol # ................................................................................................................................................... 22

G6: Type of Report........................................................................................................................................................................... 23

G7: Adverse Event Term(s).............................................................................................................................................................. 23

G8. Manufacturer Report Number For all manufacturers:.............................................................................................................. 23

SECTION H: DEVICE MANUFACTURERS ONLY ...................................................................................................................................... 24

H1: Type of Reportable Event........................................................................................................................................................... 24

H2: If Follow-up, What Type?........................................................................................................................................................... 24

H3: Device Evaluated by Manufacturer?.......................................................................................................................................... 24

H4: Device Manufacture Date .......................................................................................................................................................... 24

H5: Labeled for Single Use................................................................................................................................................................ 24

H6: Adverse Event Problem.............................................................................................................................................................. 24

H7: If Remedial Action Initiated, Check Type ................................................................................................................................... 25

H8: Usage of Device ......................................................................................................................................................................... 25

H9: If action reported to FDA under 21 USC 360i(g), list correction/removal reporting number..................................................... 25

H10: Related Report Number........................................................................................................................................................... 25

H11: Additional Manufacturer Narrative.......................................................................................................................................... 25

APPENDIX 1 .......................................................................................................................................................................................... 26

APPENDIX 2 .......................................................................................................................................................................................... 27
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• All entries should be typed or printed in a font no smaller than 8 point.

• Complete all sections that apply. If information is unknown, not available or does not apply, the section

should be left blank.

• Dates should be entered as dd-mmm-yyyy (e.g., October 12, 2019 = 12 Oct 2019). If exact dates are unknown,

provide the best estimate.

• For narrative entries, if the fields do not provide adequate space, attach an additional page(s). The following

specific information is to be incorporated:

• Include the word continued at the end of each field of FDA Form 3500A that has additional information

continued onto another page

• Identify all attached pages as Page of

•Indicate the appropriate section and block number next to the narrative continuation

• Display the User Facility, Importer, or Manufacturer/ Compounder report number in the upper right corner as

applicable

• Include the firm’s or facility’s name in the upper right corner as well, if the report is from a user facility,

importer, or manufacturer

• If the case report involves more than two (2) suspect products attach another copy of Form FDA 3500A, with

only section C filled in as appropriate.

• For a user facility, if more than one medical device is suspected to have caused or contributed to a patient death

or serious injury, the user facility can submit one report for the event. Prepare a complete Form FDA 3500A for

the device that is most likely to have caused or contributed to the event and a separate Form FDA 3500A with

only section D (Suspect Medical Device) and Blocks F9, F10, F13, and F14 filled in for each additional device.

Identify each report as device 1, device 2, etc.

• A user facility is required to report a device-related death or a device-related serious injury to the manufacturer

and to report a device-related death to FDA.

• Manufacturers must prepare and submit a complete Form FDA 3500A for each suspect device. Each Form

FDA 3500A will be given a separate Manufacturer Report Number.

• If the suspect medical device is a single use device that has been reprocessed for use in humans, then the

reprocessor is the manufacturer. The manufacturer can be either an Original Equipment Manufacturer (OEM), or

a reprocessor of Single-Use Devices, which also can be a User Facility that reprocesses Single-Use Devices.

(See the following table.)

Subject Device is: Manufacturer is:

Single Use Device Original Equipment Manufacturer 

(OEM)

Device designed to be reused Original Equipment Manufacturer 

(OEM)

GENERAL INSTRUCTIONS - For Form FDA 3500A MedWatch (for Mandatory reporting)
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Subject Device is: Manufacturer is:

Single Use Device, reprocessed for 

reuse

Reprocessor

Single Use Device, reprocessed by 

Hospital or Health Care Facility

Hospital or Health Care Facility

• If no suspect medical device is involved in a reported adverse event (i.e., when reporting ONLY a suspect

drug, biologic, or cosmetic product), ONLY sections A, B, C, E, and G are to be filled out:

• Section G (All manufacturers) may be substituted for section D (Suspect medical device) on the front of the

form to enable the submission of a one page form

• If section G is reproduced on the front of the form it must be an identical reproduction of the original

section G

• When reporting ONLY a cosmetic product, the sections and/or subsections/blocks that are not

relevant to cosmetics should be left blank.

• All submissions must be made in English, including foreign literature reports.

• Vaccines: adverse events involving vaccines should be reported to the Vaccine Adverse Event Reporting

System (VAERS), http://vaers.hhs.gov/index. For additional information or assistance with filing a VAERS

report, call: 1-800-822-7967.

• Animal Drug, Device, Pet Food and Livestock Feed Problems – report problems to FDA’s Center for

Veterinary Medicine

• Tobacco products – report health or product problems to the Safety Reporting Portal (SRP) https://www.

safetyreporting.hhs.gov or call 1-877-287-1363.

• Food or dietary supplement products, or cosmetic products.

– Reported to the SRP shouldfollowtheinstructionsat: https://www.safetyreporting.hhs.gov/SRP2

• Devices: Federal law provides that user facility reports that are required by law may not be used in

private civil litigation actions unless the party who made the report had knowledge the report contained

false information. 21 USC 360i(b)(3)

• Cosmetic Products: Responsible persons submitting serious adverse event reports for cosmetic products

using Form FDA 3500A [Form FDA 3500A is downloadable and fillable at MedWatch: The FDA Safety

Information and Adverse Event Reporting Program - Mandatory (PDF)] should include a copy of the label on

or within the retail packaging of the cosmetic product, along with any information that can be provided to

support the report, such as scans of labels and images of the serious adverse event. This may be submitted

to FDA: via email at: CosmeticAERS@fda.hhs.gov

Or by mail to:

FDA CDER Mail Center

Attn: Cosmetics MedWatch reports

White Oak Campus, Building 22, G0207

10903 New Hampshire Ave.

Silver Spring, MD 20993

GENERAL INSTRUCTIONS - For Form FDA 3500A MedWatch (for Mandatory reporting)
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FRONT PAGE

At the top of the front page enter the page number and total number of pages submitted (include attachments in 

the total) where the words Page of are indicated.

On the top-right corner of the front page, enter the Manufacturer report number, User Facility report number, or 

Importer report number in the correspondingly labeled box. Enter both report numbers, if applicable, to crossreference this report with a report from another source on the same event. For medical devices, the crossreference report number should be left blank in the section and instead entered in H11: Additional Manufacturer 

Narrative. For cosmetic products, the User Facility/Importer Report # and Exemption/Variance # should be left 

blank in this section.

Manufacturer report # (mfr report #): This is the unique identifier used by the manufacturer for this report. For a 

follow-up report, the manufacturer report number must be identical to the number assigned to the initial report. The 

manufacturer report number is also entered in block G8 on the back of the form.

• For device manufacturers: The report number consists of three components: the manufacturer’s FDA

registration number for the manufacturing site of the reported device, the 4-digit calendar year, and a

consecutive 5-digit number for each report filed during the year by the manufacturer (e.g., 1234567-2016-

00001, 1234567- 2016-00002). If the manufacturing site does not have a registration number, then FDA will

assign a temporary one to be used until the site is officially registered.

• For drug and biologics manufacturers and for responsible persons for cosmetic products: The “mfr report #” is

the number that the manufacturer or the responsible person chooses to uniquely identify the report, and should

conform to any applicable regulations or guidances.

• For human cell, tissue, and cellular and tissue- based product (HCT/P) manufacturers: The report number

should consist of three numbers separated by dashes. The first number will be the 10-digit FDA Establishment

Identifier (FEI) number, which was assigned to you as part of the Human Cells and Tissue Establishment

Registration (HCTERS). The second number should be the year that you are submitting the report. The last

number should be a consecutive 5-digit number for each report filed during the year by the manufacturer.

Example: 1234567890-2016-00005.

UF/Importer report #: This is the unique identifier used by the user facility or the importer for this report. For a 

follow-up report, the UF/Importer report number must be identical to the number assigned to the initial report.

The UF/ Importer report number is also entered in block F2 on the back of the form.

• The user facility report number consists of three components: the facility’s 10-digit Health Care Financing

Administration (HCFA) number, the 4-digit calendar year, and a consecutive 4-digit number for each report filed

during the year by the facility (e.g., 1234567890-2016- 0001, 1234567890-2016-0002). If the HCFA number has

fewer than 10 digits, enter ONLY these numbers, leaving the remainder blank (zeros will be automatically filled

in by the system). If a facility does not have a HCFA number, the first report and any subsequent reports should

be submitted with all zeros in the HCFA space (e.g., 0000000000-2016-0001), and FDA will assign a number to

be used in future reports. If a facility has more than one HCFA number, the facility must select one of those

numbers as the primary number and use it for subsequent submissions.

If a user facility has multiple sites, the primary site can report centrally and use one reporting number for all sites

IF the primary site provides an addendum that identifies the name, address, and HCFA number for the other

sites.

GENERAL INSTRUCTIONS - For Form FDA 3500A MedWatch (for Mandatory reporting)
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• The importer report number consists of three components: the FDA-assigned registration or identification

number for the importer of the device, the 4-digit calendar year, and a consecutive 5-digit number for each

report filed during the year by the importer (e.g., 1234567-2016-00001, 1234567-2016-00002). If an importer

does not have an assigned identification number, it should use all zeros in the appropriate space on the initial

report, and continue to use zeros on subsequent reports until the FDA- assigned number is received. The

importer would still enter the 4-digit calendar year and 5-digit sequence number.

• The Exemption/Variance Number identifies reports being submitted under the conditions of an FDA approved

exemption or variance per 21 CFR Part 803.19. If the report being submitted is not the subject of an approved

exemption or variance, the field should not be completed unless instructed by the FDA to use this field for a

specific purpose.

• Note: In cases where a reporting site is registered as both a manufacturer and an importer, and the registration

and/or FDA-assigned identification numbers are identical for both, then the 5-digit sequence number for reports

submitted during the year by either one may NOT be duplicated. For example, for devices manufactured by the

firm, the report number would consist of the registration number, calendar year, and a consecutive 5-digit

number (e.g., 1234567-2016-00001, 1234567-2016-00002, and so on). For devices imported by the firm, the

registration number and year would remain the same, but the 5-digit sequence number must be different (e.g.,

1234567-2016- 00003, 1234567-2016-00004, and so on).

GENERAL INSTRUCTIONS - For Form FDA 3500A MedWatch (for Mandatory reporting)
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SECTION A: PATIENT INFORMATION

Complete a separate form for each patient. If you are a user facility reporting an event where multiple patients were adversely 

affected at the same time through the use of one device, you do not need to file a separate form FDA 3500A for each patient 

as long as you:

• Indicate the number of patients in block B5 (describe event or problem).

• Prepare a complete form FDA 3500A for one patient and attach additional 3500As with section A and blocks B2, B5, B6, B7,

D10, F2 and F10 filled in for each additional patient [Be sure to identify all forms with the user facility report number].

• Enter the corresponding patient identifier in block A1 for each patient involved in the event.

Mother-infant/fetus report(s) are those cases in which either a mother or a fetus/breast feeding infant, or both, sustain an 

adverse event that the initial reporter considers possibly associated with a product administered to or a device used on the 

mother during pregnancy. Several general principles are used for filing these reports:

• If the event did not affect the infant/fetus, report only on the mother.

• For those cases describing fetal death, miscarriage or abortion, report the mother as the patient in the report.

• When ONLY the infant/fetus has an adverse reaction/ event (other than fetal death, miscarriage or abortion), the information

provided in section A applies to the infant/ fetus. However, the information in section C or D would apply to the mother who

was the source of exposure to the product or device.

• When a newborn baby is found to have a congenital anomaly/birth defect that the initial reporter considers possibly

associated with a product administered to or device used on the mother during pregnancy, the patient is the newborn baby.

• If both the mother and the infant/fetus sustain adverse events, two reports should be provided and linked using the

narrative field in block B5.

A1: Patient identifier

Provide the patient’s initials or some other identification code number that will allow both the submitter and the initial reporter (if 

different) to locate the case if contacted for follow- up. Do not use the patient’s name, medical record number or social security 

number.

The patient’s identity is held in strict confidence by FDA and protected to the fullest extent of the law. The FDA will not 

disclose the reporter’s identity in response to a request from the public, pursuant to the Freedom of Information Act.

If no patient was involved, enter ‘none’.

A2: Age or Date of Birth

Enter the patient’s birth date, if known, or the patient’s age at the time of event onset. Provide the most precise information

available if the exact age is unknown.

For age, indicate years, months, and/or days.

• If the patient is 3 years or older, use years (e.g., 4 years).

• If the patient is less than 3 years old, use months (e.g., 34 months).

• If the patient is less than 1 month old, use day(s) (e.g., 15 day(s)).

A3: Sex/Gender

a. Sex: Enter the patient’s sex at birth (the sex that a person has or was assigned to at birth).

b. Gender: Enter the patient’s current gender (how the patient thinks of themself).

Choose only one response. If the adverse event is a congenital anomaly, report the sex of the child.

A4: Weight

Indicate whether the weight is in pounds (lbs.) or kilograms (kgs). Make a best estimate if exact weight is unknown.
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A5: Ethnicity

Indicate the ethnicity of the patient. Choose only one response. Please do NOT make a best guess.

A6: Race

Indicate the race of the patient as reported by the patient. You may choose multiple answers for race. Please do NOT make a 

best guess.
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SECTION B: ADVERSE EVENT OR PRODUCT PROBLEM

B1: Type of Report

Choose the appropriate box. Both boxes should be checked if a product problem has or may have caused or contributed to the 

adverse event.

Adverse event: Any incident where the use of a product (drug or biologic, including human cell, tissue, or cellular or tissuebased product (HCT/P), at any dose, or a medical device (including in vitro diagnostic products), or cosmetic product is 

suspected to have resulted in an adverse outcome in a patient.

Product problem (e.g., defects/malfunctions): Any report regarding the quality, performance, or safety of any medical 

product. This category is selected when reporting device malfunctions that could lead to a death or serious injury if the 

malfunction were to recur.

B2: Outcomes attributed to adverse event

Indicate ALL that apply to the reported event:

Drugs, Biologics and Cosmetic Products: Only mark a box in this section if the adverse event meets the regulatory 

definition of serious in 21 CFR 314.80(a), 21 CFR 600.80(a) and Section 605 of the FD&C Act, respectively.

Human Cells, Tissues, and Cellular and Tissue- Based Products (HCT/Ps): An adverse reaction must be reported to 

FDA if it involves a communicable disease and according to 21 CFR 1271.350a:

(i) Resulted in death;

(ii) Is life-threatening;

(iii) Results in permanent impairment of a body function or permanent damage to body structure, or

(iv) Necessitates medical or surgical intervention, including hospitalization.

Medical Devices: An adverse event which must be reported to FDA is a device-related death or a device- related serious injury 

as defined in 21 CFR 803.3:

A serious injury means an injury or illness that:

(1) Is life-threatening,

(2) Results in permanent impairment of a body function or permanent damage to a body structure, or

(3) Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent

damage to a body structure. Permanent means irreversible impairment or damage to body structure or function,

excluding trivial impairment or damage.” https://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/

cfrsearch.cfm?fr=803.3

Death: Check if death was an outcome of the adverse event, or if the cause of the death is unknown. Include the date of death, 

if known.

DO NOT check if: The patient died while using a medical product, but there was no suspected association between the death 

and the use of the product

• A fetus is aborted because of a congenital anomaly, or is miscarried.

Life-threatening: Check if suspected that:

• The patient was at substantial risk of dying at the time of the adverse event.

• Use or continued use of the device might have resulted in the death of the patient.
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SECTION B: ADVERSE EVENT, PRODUCT PROBLEM (Continued)

Hospitalization (initial or prolonged): Check if admission to the hospital or prolongation of hospitalization was a result of the 

adverse event.

DO NOT check if:

• A patient in the hospital received a medical product and subsequently developed an otherwise nonserious

adverse event, UNLESS the adverse event prolonged the hospital stay.

DO check if:

• A patient is admitted to the hospital for one or more days, even if released on the same day.

• An emergency room visit results in admission to the hospital.

Note: Emergency room visits that do not result in admission to the hospital should be evaluated for one of the other serious 

outcomes (e.g., life-threatening; required intervention to prevent permanent impairment or damage; other serious (medically 

important event).

Disability or Permanent Damage: Check if the adverse event resulted in a substantial disruption of a person’s ability to 

conduct normal life functions. For cosmetic products, check if the adverse event resulted in a persistent or significant 

disability or incapacity.

Congenital Anomaly/Birth Defect: Check if suspected that exposure to a product prior to conception or during 

pregnancy may have resulted in an adverse outcome in the child.

Required Intervention to Prevent Permanent Impairment/ Damage: If either situation may be due to the use of a medical 

device and medical or surgical intervention was necessary to:

• Preclude permanent impairment of a body function.

• Prevent permanent damage to a body structure.

Other Serious (Important Medical Events):

• Check when, based on appropriate medical judgment, the event may jeopardize the patient and may require medical

or surgical intervention to prevent one of the other outcomes. Examples include allergic bronchospasm requiring

emergency treatment, blood dyscrasias or convulsions that do not result in hospitalization, or the development of

drug dependency or drug abuse. For human cells, tissues, and cellular and tissue- based products

(HCT/P’s), such interventions could include antibiotics in response to a positive culture or clinical suspicion of

an infection, but not as prophylaxis for infection.

• Cosmetic Products: Check if the other categories are not applicable, such as when the adverse event results in an

infection or significant disfigurement (including serious and persistent rashes, second- or third-degree burns,

signification hair loss, or persistent or significant alteration of appearance) other than as intended, under conditions of

use that are customary or usual. Describe the outcomes in the actual narrative of the event in block B5.

• Devices: Check ONLY if the other categories are not applicable to the event. Describe the patient outcome in the actual

narrative of the event in block B5.

B3: Date of Event

Provide the actual or best estimate of the date of first onset of the adverse event. If day is unknown, month and year are 

acceptable. If day and month are unknown, year is acceptable.

• When a newborn baby is found to have a congenital anomaly, the event onset date is the date of birth

of the child.

• When a fetus is aborted because of a congenital anomaly, or is miscarried, the event onset date is the date pregnancy is

terminated.
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If information is available as to time during pregnancy when exposure occurred, indicate that information in narrative block 

B5.

B4: Date of this Report

For all mandatory reports filed for Medical Devices, Drugs, Biologics, including Human Cells, Tissues, and Cellular and TissueBased Products, and Cosmetic Products enter the date the report is submitted to the FDA . Dates should be entered as ddmmm-yyyy (e.g., October 12, 2020 = 12 Oct 2020). 

B5: Describe Event or Problem

For an adverse event: Describe the event in detail using the reporter’s own words, including a description of what happened 

and a summary of all relevant clinical information (medical status prior to the event; signs and/or symptoms; differential 

diagnosis for the event in question; clinical course; treatment; outcome, etc.). If available and if relevant, include synopses of 

any office visit notes or the hospital discharge summary.

To save time and space (and if permitted by the institution), attach copies of these records with any confidential information 

deleted. DO NOT contain any personal identifiable information (PII) or proprietary information, if PII or proprietary information 

is critical to understand the event, that information should be included in B6 Related

Test/Laboratory Data or B7 Other Medical History, including Preexisting Medical Conditions. The initial reporter’s identity should 

be provided in full in section E.

Information as to any environmental conditions that may have influenced the event should be included, particularly when 

(but not exclusive to) reporting about a device.

For HCT/Ps, provide information on the type of surgical procedure and anatomical site of implantation, and the date of onset of 

symptoms.

Results of relevant tests and laboratory data should be entered in block B6. (see instructions for B6).

Preexisting medical conditions and other relevant history belong in block B7. Be as complete as possible, including time 

courses for preexisting diagnoses (see instructions for B7).

For Cosmetic Products we encourage to provide other available, and relevant information pertinent to this adverse event 

such as:

• The brand name

• If the cosmetic product is for professional use only

• If available, include details such as amount, frequency of use, the start and stop dates of the use.

For a product problem: Describe the problem (quality, performance, or safety concern) in sufficient detail so that the 

circumstances surrounding the defect or malfunction of the medical product can be understood. If available, the results of 

any evaluation of a malfunctioning device and, if

known, any relevant maintenance/service information should be included in this section.

B6: Relevant Test/Laboratory Data, Including Dates

Provide all appropriate information, including relevant negative test and laboratory findings, in order to most completely convey 

how the medical work-up/assessment led to strong consideration of medical-product-induced disease as etiology for clinical 

status, as other differential diagnostic considerations were being eliminated.

Include:

• Any relevant baseline laboratory data prior to the administration or use of the medical product.

• All laboratory data used in diagnosing the event.

• Any available laboratory data/engineering analyses (for devices) that provide further information on the course of the

event.
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If available, include:

• Any pre- and post-event medication levels and dates (if applicable).

• Synopses of any relevant autopsy, pathology, engineering, or lab reports.

If preferred, copies of any reports may be submitted as attachments, with all confidential information deleted. DO NOT 

identify any patient, physician or institution by name. The initial’s reporter’s identity should be provided in full in section E.

B7: Other Relevant History, Including Preexisting Medical Conditions:

If available, provide information on:

• Other known conditions in the patient, e.g.,

• Hypertension

• Diabetes mellitus

• Renal/hepatic dysfunction

• Recent infection

• Significant history

• Allergies

• Pregnancy history

• Smoking and alcohol use

• Drug abuse, etc.
FORM FDA 3500A SUPPLEMENT (12/23) – FORM INSTRUCTIONS | Previous edition is obsolete 

Page 14 of 28

SECTION C: SUSPECT PRODUCT(S)

For adverse event reporting, a suspect product is one that the initial reporter suspected was associated with the adverse 

event. Use section C to report events that involve one of the following products:

• Prescription or Over-The-Counter (OTC) medication

• Biologic products, such as blood and blood products, human cells and tissues used for transplantation (e.g. tendons,

ligaments and bone) and gene therapy

• Nutrition product, such as a vitamin or mineral, herbal remedy, infant formula, or medical food or beverage

• Cosmetic product

In block C2 enter other concomitant medical products (drugs, biologics, including human cells, tissues, and cellular and tissuebased products (HCT/Ps), and medical devices, etc.) that the patient was using at the time of the event but are NOT thought by 

the initial reporter to be involved in the event.

Up to two (2) suspect products may be reported on one form (#1 = first suspect product, #2 = second suspect product). 

Attach an additional form if there were more than two suspect products for the reported adverse event.

For cosmetic products, fill out ONLY the blocks that are relevant to cosmetic products.

C1: Name, Strength, Manufacturer/Compounder

Space provided to identify two products. Use the trade name as marketed (e.g., if there is a Structured Product Labeling (SPL) 

for the product, then use the Product name and/or Active ingredient as it appears in SPL; If there is no SPL and a label is 

attached to the report, then use the same naming convention as in the attached label). If unknown or if no trade name, use the 

generic name (with the manufacturer or labeler’s name, if known). For foreign reports, use both the foreign trade name and the

U.S. generic name.

For human cells, tissues, and cellular and tissue-based products (HCT/Ps), please provide the common name of the HCT/P 

and the name of the manufacturer. You can also indicate if the HCT/P has a proprietary or trade name, in addition to the 

common name of the HCT/P (e.g., Brand A bone chips, or Brand B skin tissue).

Examples: Achilles tendon, Iliac crest bone, Islet Cells, or human skin.

Lot # 

If known, include the lot number(s) with all product problem reports, or any adverse event report with a biologic or medication.

NDC # or Unique ID

The National Drug Code (NDC #) is a universal product identifier for human drugs. NDC is a three-segment number; zeros and 

dashes should be included as they appear on the original manufacturer’s product label and/ or packaging. NDC numbers are 

particularly useful to the FDA in investigating drug product quality problems.

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) must have a Unique ID number to track the 

product. For reports involving HCT/Ps, this unique ID should be provided in this box.

C2: List Medical Products and Treatment Given at the Same time of the Event and Date

List and provide therapy dates for any other products (drugs, biologics, including HCT/Ps, medical devices, etc.) that a patient 

was using at the time of the event. For cosmetic reports include all related cosmetic products used at the same time. Do not 

include products used to treat the event.

C3: Dose, Frequency & Route Used

Describe how the product was used by the patient or the consumer (e.g., 500 mg QID orally or 10 mg every other day IV or 

number of applications, area of application). For reports involving overdoses, the amount of product used in the overdose 

should be listed, NOT the prescribed amount.

• See APPENDIX for list of Routes of Administration
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C4: Treatment/Therapy/Usage Start and Stop Dates

Provide the date treatment/therapy administration or usage was started (or best estimate) and the date stopped (or best 

estimate). If no dates are known, an estimated duration is acceptable (e.g., 2 years) or, if treatment/therapy/usage was less 

than one day, then duration is appropriate (e.g., 1 dose or 1 hour for an IV).

For human cells, tissues, and cellular and tissue-based products HCT/Ps, provide the date of transplant and if applicable, the 

date of explantation.

NOTE: Use block C4 to record the date that a diagnostic test was performed for reports that involve an in vitro diagnostic 

product or radiation therapy.

C5: Diagnosis for Use

Provide the indication for which the product was prescribed or used in this particular patient.

C6: Product Type

If the product is Over-The-Counter (OTC), Compounded, Generic or a Biosimilar, please check the best option that best fits 

this medical product.

C7: Expiration date

Include ONLY with all product problem reports and events involving human cells, tissues, and tissue and cellular-based 

products (HCT/Ps).

C8: Event Abated After Use Stopped or Dose Reduced

In addition to checking the appropriate box, provide supporting lab tests and dates, if available, in block B6.

C9: Event Reappeared After Reintroduction

In addition to checking the appropriate box, provide supporting lab tests and dates, if available, in block B6.
SECTION D: SUSPECT MEDICAL DEVICE

In block D10, report other concomitant medical products (drugs, biologics, including human cells, tissues, and cellular and 

tissue-based products (HCT/Ps), or medical devices, etc.) that the patient was using at the time of the event that are not 

thought to be involved in the event.

For in vitro diagnostic products and radiation therapy products that are reported in section D, use block C4: Therapy Dates 

to record the date that diagnostic tests are performed.

D1: Brand Name

The trade or proprietary name of the suspect medical device as used in product labeling or in the catalog (e.g., Flo-Easy 

Catheter, Reliable Heart Pacemaker, etc.). This information may 1) be on a label attached to a durable device, 2) be on a 

package of a disposable device, or 3) appear in labeling materials of an implantable device.

Single use reprocessed devices may bear the OEM’s brand name. If the suspect device is a reprocessed single-use device, 

enter “NA”.

D2a: Common Device Name

The generic or common name of the suspect medical device or a generally descriptive name (e.g., urological catheter, heart 

pacemaker, patient restraint, etc.). Do not use broad generic terms such as “catheter”, “valve”, “screw”, etc.

D2b: Procode

Medical devices are classified under 21 CFR Parts 862-892. The assigned FDA Product Classification Code (procode) can be 

identified using the Product Classification Database search page at http://www.accessdata.fda.gov/scripts/cdrh/

cfdocs/cfPCD/classification.cfm

Manufacturers and importers should include the procode for their devices. User facilities are encouraged to try to identify the 

procode for the devices reported on the form FDA 3500A. If you are unable to determine the product code, for a device, 

contact FDA at (800) 638-2041 for assistance.

D3: Manufacturer Name, City and State

If available, enter the full name, city, and state of the manufacturer of the suspect medical device. If block D8 below is 

‘Yes’, enter the name, city and state of the reprocessor.

D4: Model #, Catalog #, Serial #, Lot #, Expiration date, Unique Device Identifier (UDI) # 

If available, provide any expiration date or any or all identification numbers associated with the suspect medical device exactly 

as they appear on the device or device labeling. This includes spaces, hyphens, etc.

• Model #: The exact model number found on the device label or accompanying packaging.

• Catalog #: The exact number as it appears in the manufacturer’s catalog, device labeling, or accompanying

packaging.

• Serial #: This number can be found on the device label or accompanying packaging; it is assigned by the manufacturer

and should be specific to each device.

• Lot #: This number can be found on the label or packaging material.

• Expiration date: If available; this date can often be found on the device itself or printed on the accompanying

packaging.

• Unique Device Identifier (UDI) #: This number can be found on the device, its label, or accompanying packaging. The

number is located below the barcode and may contain numbers, letters and special characters such as (), /, $, +, =

} etc. The UDI begins with one of the following three elements:

(01)

+

=

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Please record all numbers, letters, parentheses, and symbols included in the UDI #. Complete information will enable 

effective parsing of the UDI into its components for use with important public health needs. Please submit all applicable UDIs 

for a given adverse event submission.

For more information regarding the UDI #, refer to the UDI webpage, https://www.fda.gov/medical-devices/ deviceadvice-comprehensive-regulatory-assistance/ unique-device-identification-system-udi-system or contact the FDA UDI 

Helpdesk at https://www.fda. gov/medical-devices/unique-device-identification- system-udi-system/fda-udi-help-desk or 

by emailing GUDIDSupport@fda.hhs.gov

D5: Operator of Device

Indicate the type (not the name) of person operating or using the suspect medical device on the patient at the time of the event 

as follows:

• Health Professional = physician, nurse, respiratory therapist, etc.

• Patient/Consumer = person being treated, parent/ spouse/friend of the patient

• Other = nurses aide, orderly, etc.

D6a: If Implanted, Give Date

For medical devices that are implanted in the patient, provide the implant date or best estimate. If day is unknown, month and 

year are acceptable. If month and day are unknown, year is acceptable.

D6b: If Explanted, Give Date

If an implanted device was removed from the patient, provide the explant date or best estimate. If day is unknown, month and 

year are acceptable. If month and day are unknown, year is acceptable.

D7a: Is this a Single-use Device that was Reprocessed and Reused on a Patient?

Indicate “Yes” or “No”

If the original equipment manufacturer (OEM) is unable to determine if their single use device was reprocessed

and reused on a patient, then the OEM should enter ‘UNK’ in Block D8 and in Block H11 (Additional Manufacturer Narrative) 

describe the efforts made to obtain the information and any responses.

D7b: If yes, Enter Name and Address of Reprocessor

Enter the name and address of the reprocessor of the single-use device.

Any entity that reprocesses single-use devices for reuse in humans is the manufacturer of the reprocessed single-use 

device.

D8: Is this device ever serviced by a Third Party?

Indicate “Yes”, “No” or “Unknown.”

D9: Is this Device Available for Evaluation?

Indicate whether the device is available for evaluation by the manufacturer. Indicate if the device was returned to the 

manufacturer and, if so, the date of the return.

Do not send the device to FDA.

D10: Concomitant Medical Products and Therapy Dates

List and provide product names and therapy dates for any other medical products (drugs, biologics, including human cells, 

tissues, and cellular and tissue-based products (HCT/ Ps), or medical devices, etc.) that the patient was using at the time of 

the event. Do not include products used to treat the event.

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SECTION E: INITIAL REPORTER

Indicate the person who initially reported the adverse event to the user facility, importer, or manufacturer.

E1: Name and Address

Please provide the name, mailing address, phone number, and email address of the person who initially reported the adverse 

event to the user facility, manufacturer, or importer, and who can be contacted to provide information on the event if follow-up is 

necessary.

For medical device reporting by user facilities, this person may or may not be the designated medical device reporting (MDR) 

contact.

E2: Health Professional

Indicate whether the initial reporter is a health professional (e.g., physician, pharmacist, nurse, etc.) or not. If not a health 

professional, complete block E3 by filling in NA.

E3: Occupation

Indicate the initial reporter’s occupation (particularly type of health professional e.g. physician assistant, and include 

specialty e.g. cardiology, if appropriate.

E4: Initial Reporter Also Sent Report to FDA

Indicate whether the initial reporter also notified or submitted a copy of this report to FDA.
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SECTION F: FOR USE BY USER FACILITY(UF)/IMPORTER – DEVICES ONLY

F1: Check one

Indicate whether the report is from a user facility or importer.

F2: User Facility/Importer Report Number

Enter the complete number of the report exactly as entered in the upper right corner of the front page. For a follow-up report, 

the UF/Importer report number must be identical to the number assigned to the initial report. See instructions on front page 

for further explanation of UF/ Importer report number.

F3: User Facility or Importer Name/Address

Enter the full name and address of the user facility or importer reporting site.

F4: Contact Person

Enter the full name of the medical device reporting (MDR) contact person. This is the person designated by the facility’s most 

responsible person as the device user facility/importer contact for this requirement. FDA will conduct its MDR correspondence 

with this individual.

The contact person may or may not be an employee of the facility. However, the facility and its responsible officials will remain 

the parties ultimately responsible for compliance with the MDR requirements.

F5: Phone Number

Enter the phone number of the MDR contact person.

F6: Date User Facility or Importer Became Aware of Event

Enter the date that the user facility’s medical personnel or the importer became aware that the device has or may have caused 

or contributed to the reported event. Dates should be entered as dd-mmm-yyyy (e.g., October 12, 2020 = 12 Oct 2020). 

F7: Type of Report

Check the appropriate box to identify the type of report being filed, i.e., an initial report of an event or a follow-up to a previously 

submitted report.

If a follow-up report, make sure that the UF/ Importer report number for the previously submitted initial report is recorded in 

block F2. In the blank provided in block F7, record the appropriate sequence of follow-up to that particular initial report (e.g., 

first follow-up report = follow- up #1, second follow-up report = follow-up #2, and so on).

Follow-up reports should not repeat material that was submitted in the initial report, but should ONLY provide additional or 

corrected information on the previously reported event.

F8: Date of this Report

Enter the date that the report was forwarded to the manufacturer and/or the FDA.

F9: Approximate Age of Device

Enter the age of the device or a best estimate (include unit of time used: e.g., month, year).
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F10: Adverse Event Problem

(refer to the MDR Adverse Event Coding webpages) 

Enter up to 3 Health Effect – Clinical Codes and 3 Medical Device Problem Codes from the Codes Manual that most 

accurately describes the event. Health Effect – Clinical codes indicate the effects that an event may have had on the patient, 

including signs, symptoms, syndromes, or diagnosis and medical device problem codes describe device failures or issues 

related to the device that are encountered during the event. If more than 3 Health Effect – Clinical Codes or more than 3 

Medical Device Problem Codes are needed, you can enter them in block H11 and identify as additional codes for “F10”.

The CDRH Event Problem Codes can be found on the Coding Resources web page online. The codes are periodically 

updated and the updated files will be found on this page.

F11: Report Sent to FDA?

Check yes or no and indicate the date sent, if applicable. User facilities are required to send reports of device- related deaths 

to FDA (21 CFR 803.30). Importers are required to send reports of device-related deaths and serious injuries to FDA (21 CFR 

803.40).

F12: Location Where Event Occurred

Check the location of the actual occurrence of the event. If none of the designated location options apply, check the Other 

box and provide the location

F13: Report Sent to Manufacturer?

Check yes or no and indicate the date sent, if applicable. User facilities are required to send reports of device- related deaths 

and device-related serious injuries to manufacturers (21 CFR 803.30). Importers are required to send reports of device-related 

deaths and device- related serious injuries and reports of malfunctions that could cause or contribute to a death or serious 

injury to manufacturers (21 CFR 803.40).

F14: Manufacturer Name/Address

Enter full name and address of the device manufacturer, if available. If the manufacturer is a reprocessor of a single- use 

device, the name and address should be identical to the information in Block D9.
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SECTION G: ALL MANUFACTURERS AND RESPONSIBLE PERSONS

This section is to be filled out by all manufacturers or responsible persons (in case of cosmetic products). NOTE: If a drug,

biologic, including human cell, tissue, and cellular and tissue-based product (HCT/P), or cosmetic product manufacturer (or 

responsible person in case of cosmetic product) is reporting an adverse event in which no suspect medical device is involved, 

section G may be identically reproduced in place of Section D on the front of the form so that a one page form may be 

submitted.

For cosmetic products, fill out ONLY the blocks that are relevant to cosmetic products.

G1: Contact Office 

(and manufacturing site for devices) or Compounding Outsourcing Facility or Responsible Person (in case of cosmetic 

products)

Enter the full name, address, and email address of the manufacturer reporting site [contact office], including contact name. If 

the manufacturing site of the device is not the same as the contact office, enter site and the name and address of the 

manufacturing site after the contact office name and address and phone number. For cosmetic products, enter the information 

of the responsible person, which means the manufacturer, packer, or distributor of a cosmetic product whose name appears 

on the label of the cosmetic product.

Compounding Outsourcing Facility (503B)

Indicate if the manufacturer is registered as 503B facility.

G2: Report Source

Check the box(es) that most accurately describe(s) how the manufacturer [contact office] became aware of the reported 

adverse event or the source from which the information about the adverse event originated.

• Foreign: Foreign sources include foreign governments, foreign affiliates of the application/license holder, foreign licensors

and licensees, foreign medical facilities, etc. The country of origin should be included.

• Study: Postmarketing, clinical trial, surveillance, or other study that involves a systematic collection of adverse events from

a protocol designed specifically to investigate product safety. For Drugs, Biologics, including HCT/ Ps and Cosmetic

Products this also includes information derived from planned contacts and active solicitation of information from patients or

consumers (e.g., company-sponsored patient support programs and disease management programs).

• Literature: If the report source is the scientific literature or an unpublished manuscript, a copy of the article or manuscript

must be attached. Foreign language articles should be translated into English. Record the date of the Article as the date

of the event (block B3), and provide a full literature citation in block H11. Drugs, Biologics, including HCT/ Ps

and Cosmetic Products: A separate 3500A form must be completed for each identifiable patient described in

the article or manuscript.

• Consumer (including attorneys): Additional information, whenever possible, should be sought from the treating

healthcare provider. A determined effort should be made to obtain additional detailed information from health

professionals for all serious reactions, adverse events & product problems initially reported by consumers. When

this additional information is obtained, the follow- up report should check health professional rather than

consumer in block G2.

• Health Professional: Physician, pharmacist, nurse, etc.

• User Facility: User facility should be checked if the manufacturer received the report from the MDR contact in a user

facility as identified in section F. The health professional should be listed as the initial reporter on the front page of the

form.
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• Company Representative: This check box would be selected if a company representative reported the event to the

contact office based on information received from a health professional. The health professional should be listed as the

initial reporter in Section E.

• Distributor/Importer: This check box would be selected for a report received from the distributor/importer of

the suspect product. The health professional or other reporter should be listed as the initial reporter on the front page of the

form.

• Other: Any source not covered by the previous categories. For drug or biologic, including HCT/P manufacturers, this

check box would be selected when submitting a follow-up to a report originally obtained from FDA through a MedWatch to

Manufacturer program transmission of a serious direct report, and the FDA-assigned report number entered into the

space provided. Other may also be used to identify when the source is another manufacturer— include the

Manufacturer Report Number of the other manufacturer.

G3: Date received by manufacturer or responsible person

(in case of cosmetic product)

This means the date when the applicant, manufacturer, responsible person, corporate affiliate, etc. receives information that 

an adverse event or medical device malfunction has occurred. This would apply to a report received anywhere in the world. 

Dates should be entered as dd-mmm-yyyy (e.g., October 12, 2020 = 12 Oct 2020). 

Follow-up reports: Use the date that the follow-up information was received.

G4: This block is for use by all manufacturers of drug, device, biological products 

[including cell, tissue, and cellular and tissue-based products (HCT/P)] and combination products.

Provide whatever information is applicable to the suspect product identified in section C or suspect medical device identified in 

section D.

If the report lists two products by the same applicant as suspect, the report should be submitted to the application file of the 

product thought by the initial reporter to be the more likely cause of the adverse event. If they are equally suspect, the report 

should be submitted to the application file of the product that is first alphabetically.

• NDA #: The new drug application (NDA) number.

• ANDA #: The abbreviated new drug application or the new drug application (NDA) number. The report should be filed to

the first approved NDA if a product has several NDAs and the specific one cannot be determined.

• IND #: The investigational new drug (IND) application number

• BLA: The 6 digit Biologics Application Number (BLA). If no BLA exists, use the 4 digit U.S. License Number.

• PMA/510(k) #: Manufacturers should identify the appropriate regulatory approval such as pre-market application (PMA) or

pre-market notification [510(k)] submission number for their approved / cleared medical device or combination product. If a

product has several applicable PMAs/510(k)s and the specific one cannot be determined, then the most recently

approved PMA or cleared 510(k) number for that intended use should be reported. [or most relevant to the device

problem].

• Combination Product: Check the box if the suspect product is comprised of a drug-device, device- biological, drugbiological, or a drug-device-biological product.

• PreANDA: Check the box if the suspect product is an investigational new drug exempt BA/BE Premarket serious

adverse events.

• Pre-1938: Check the box if the suspected product was marketed prior to 1938 and does not have an application #.

• OTC Product: Check the box if the suspect Monograph product or medical device can be purchased over- the- counter

(without a prescription).

G5: Give IND/Pre ANDA Protocol # 

This block is for use by drug and biologic, including HCT/P manufacturers only. If the form is being used as a written IND 

safety report, enter the protocol number.
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G6: Type of Report

Check all boxes that apply to reported event:

• 5-day: As specified in the device regulations, for reports of adverse events that necessitate remedial action to prevent an

unreasonable risk of substantial harm to the public health, or are required by FDA by written notice.

• 7-day: As specified in 21 CFR 606.170(b), blood collection or blood transfusion fatalities should be reported within 7 days

of the fatality.

• 15-day: As specified in the drug, biologic, including human cell, tissue, and cellular and tissue- based product (HCT/P),

and cosmetic products regulations or requirements, for reports of serious and unexpected adverse events.

• 30-day: As specified in device regulations, for initial reports of a device that has or may have caused or contributed to a

death or serious injury or for a device malfunction that would be likely to contribute to a death or serious injury if it were to

recur.

• Periodic: As specified in the drug and biologic regulations, for reports of serious labeled and non- serious (labeled

and unlabeled) adverse events.

• Initial: Check if the report is the first submission of a manufacturer report. For devices, this is the 30-day report.

• Follow-up: Check if the report is a follow-up to a previously submitted report.

– Follow-up reports on devices should not repeat material that was submitted in the initial report but should only provide

additional or corrected information on the previously reported event.

– Follow-up reports on drugs, biologics, including HCT/Ps, and cosmetic products should contain information that was

submitted in the original report if the information is still correct.

– If a follow-up report, make sure that the manufacturer report number for the previously submitted initial report is recorded

in block G8. In the blank provided in block G6 after follow-up, record the appropriate sequence of follow-up to that

particular initial report (e.g., first follow-up report = follow-up #1, second follow-up report = follow-up #2, and so on).

– For drug and biologic, including HCT/P manufacturers: If submitting a follow-up to a report originally obtained from FDA

through a MedWatch to Manufacturer program transmission of a serious direct report, check the “Other” box in block G2

and enter the FDA-assigned report number there.

G7: Adverse Event Term(s) 

[for use by drug, biologic, including human cell, tissue, and cellular and tissue-based product (HCT/P), and cosmetic 

products manufacturers (or responsible persons, in case of cosmetic products) only]

Include a list of adverse event terms that most accurately characterize the adverse event described in narrative format in block 

B5. Terms should be listed with the most important term(s) first. The terminology may be an accepted standard (e.g., MEDDRA 

or WHOART), a verbatim term, or the manufacturer’s own terminology.

G8. Manufacturer Report Number For all manufacturers:

Enter the Manufacturer report number exactly as it appears in the “Mfr Report #” field in the upper right corner of the first page. 

For a follow-up report, the Manufacturer report number must be identical to the number assigned to the initial report.

For drug and biologic manufacturers, and cosmetic products responsible person:

The manufacturer report number is the number the manufacturer or responsible person chooses to uniquely identify the 

report, and should conform to any applicable regulations or guidances.

For human cell, tissue, and cellular and tissue-based product (HCT/P) manufacturers: The report number should consist 

of three numbers separated by dashes. The first number will be the 10-digit FDA Establishment Identifier (FEI) number, which 

was assigned to you as part of the Human Cells and Tissue Establishment Registration (HCTERS). The second number

should be the year that you are submitting the report. The last number should be a consecutive 5-digit number for each report 

filed during the year by the manufacturer. Example: 1234567890- 2016-00005.
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SECTION H: DEVICE MANUFACTURERS ONLY

H1: Type of Reportable Event

Check all the appropriate boxes that apply to this report. These choices represent the categories of events that device 

manufacturers are required to report.

• Death: Check only if the MDR reportable event represents a device-related death.

• Serious injury: An adverse event that is life- threatening; results in permanent impairment of a body function or permanent

damage to a body structure; or necessitates medical or surgical intervention to preclude permanent impairment of a body

function or permanent damage to a body structure.

• Malfunction: See the guidelines. (“See the guidelines” refers to the applicable sections in 21 CFR Part 803 reporting

guidelines associated with device malfunctions).

• Summary Report: Only check this box if the report is submitted as part of the Voluntary Malfunction Summary Reporting

Program (see eligibility criteria here: https:// www.fda.gov/medical-devices/medical-device-safety/ medical-device-reportingmdr-how-report-medical-device- problems#malfunction), or if you have an FDA-approved exemption/variance for submitting

MDRs in summary format under 21 CFR Part 803.19 (you must have a letter from FDA indicating approval of such an

exemption/variance). Make sure you indicate the number of events being summarized as part of the Summary

Report.

H2: If Follow-up, What Type?

Check the box(es) that most accurately describes the nature of the follow-up report.

• Correction: Changes to previously submitted information.

• Additional information: Information concerning the event that was not provided in the initial report because it was not

known/available when the report was originally submitted.

• Response to FDA request: Additional information requested by FDA concerning the device/event.

• Device evaluation: Evaluation/analysis of device.

H3: Device Evaluated by Manufacturer?

Check the box marked Yes if an evaluation was made of the suspect or related medical device and provide a summary of 

evaluation in H11: Additional Manufacturer Narrative.

If an evaluation of a returned suspect or related medical device was not conducted, check the box marked No and provide a 

justification to explain why not in H11: Additional Manufacturer narrative or enter the appropriate code from the codes manual

in H6: Adverse Event Problem. “

H4: Device Manufacture Date

Enter the month and year of manufacture of the suspect medical device using a dd-mmm-yyyy date format.

H5: Labeled for Single Use

Indicate whether the device was labeled for single use or not. If the question is not relevant to the device being reported 

(e.g., an X-ray machine), check No.

H6: Adverse Event Problem

Space has been provided for a manufacturer to enter Health Effect – Clinical Code, Health Effect – Impact Code, and Medical 

Device Problem code. A manufacturer also enters codes for the categories of type of investigation, investigation findings, and 

investigation conclusion. Enter the applicable codes from the codes manual using at least one code in each of the categories 

listed. Conclusion codes must be entered even if the device was not evaluated.
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H7: If Remedial Action Initiated, Check Type

Indicate the applicable action(s). If other, specify the type of action in the space provided. Most of these terms are defined 

or further explained in the Act or in the FDA regulations concerning remedial action (see 21 USC 360h and 21 CFR Parts 

7, 803 and 806).

H8: Usage of Device

Indicate whether the use of the suspect medical device was the initial use, reuse, or unknown.

If a manufacturer receives an adverse event report that indicates that the event was caused by or contributed to by reuse of a 

single use device they manufactured, this block is to be appropriately marked and the facts of the firm’s investigation provided 

with an explanation of how the reuse of the product contributed to the outcome. The appropriate manufacturer Result codes for 

reuse are also to be entered into H6.

H9: If action reported to FDA under 21 USC 360i(g), list correction/removal reporting number

Enter the correction/removal number following the format directed by 21 CFR 807. If a firm has not submitted a 

correction/removal report to FDA, but FDA has assigned a recall number to the corrective action, the recall number may 

be used.

H10: Related Report Number

If report(s) are identified for the same event and submitted by different reporter(s), enter the number for such report(s).

H11: Additional Manufacturer Narrative

Enter any additional information, evaluation, or clarification of data presented in previous sections. Do not duplicate 

information that has already been provided elsewhere. PII or proprietary information should not be included in H11 unless it 

is critical to understand the investigation or cause of the event.

All corrections should only be reported in the specific sections of the form at the time the supplemental report is being 

submitted.
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For each term, read as Description – ICH-M2 Numeric Code

APPENDIX 1

ROUTES OF ADMINISTRATION: ICH LIST AND CODES
FORM FD A 3500A SUPPLEM ENT (11/23) Page 28 of 28 – FORM INSTRUCTIONS | Pr evi ous editi on i s obsolete

Examples of C1 Suspect Product Name

Correct: Miracle Wonder Drug – The stated Trade name is the same as in the product label.

Incorrect: Amazing Drug (paracetamol) – If providing a foreign product name and its generic name, use the U.S. generic name 

(in this case, acetaminophen).

Incorrect: MWD (APAP) – Do not use abbreviations.

Incorrect: Miracle Wonder DrugOTC® – Any additional information that should be captured in other sections of the form, for 

example in G5, should not be added to the Suspect Product name in C1

FORM FDA 3500A SUPPLEMENT (12/23) – FORM INSTRUCTIONS | Previous editionis obsolete Page 28 of 28

APPENDIX 2

EXAMPLES FOR POPULATING SECTION C1 SUSPECT PRODUCT(S) NAME