FDA USE ONLY 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 

FORM 3500A 

For use by user-facilities, importers, distributors 

and manufacturers for MANDATORY reporting 

Form FDA-3500A (11/22) Page 1 of 7 PSC Publishing Services (301) 443-6740 EF 

(PREVIOUS EDITION OBSOLETE) 

Form Approved: OMB No. 0910-0291 

Expires: 6-30-2025 

See PRA statement on page 6. 

Mfr report # 

UF/Importer Report # 

Exemption/Variance # 

Note: For date prompts of “dd-mmm-yyyy” please use 2-digit day, 3-letter month abbreviation, and 4-digit year; for example, 01-JAN-1900. 

A. PATIENT INFORMATION 

1. Patient Identifier (In confidence) 2. Age or Date of Birth (e.g., 01-Jan-1900) 

3a. Sex: Enter the patient’s sex at birth 3b. Gender: Enter the patient’s current gender (how the patient thinks of themself).

4. Weight 5. Ethnicity (Check one) 6. Race (check all that apply)

 lb

 kg 

B. ADVERSE EVENT OR PRODUCT PROBLEM 

1. Type of Report (check all that apply) 2. Outcome Attributed to Adverse Event (check all that apply)

 Adverse Event 

Product Problem 

(e.g., defects/malfunctions) 

3. Date of Event (01-JAN-1900) 4. Date of this Report (01-JAN-1900)

Reset Form 

Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the event.

* Please see instructions 

 American Indian/Alaska Native

 Asian

 Black or African American

 Native Hawaiian/ 

Other Pacific Islander

 White 

(the sex that a person has or was 

assigned to at birth).

 Male

 Female

 Hispanic/Latino

 Not Hispanic/Latino 

 Cisgender man/boy 

(gender corresponds with birth sex)

 Cisgender woman/girl 

(gender corresponds with birth sex)

 Transgender man/trans man/ 

female-to-male (FTM)

Year(s) 

Month(s)

 Week(s)

 Day(s) 

 Transgender woman/trans woman/ 

male-to-female (MTF)

 Other gender category; please specify: 

 Decline to answer 

 Undifferentiated 

 Decline to answer 

 Death – 

 Life-threatening

Hospitalization (initial or prolonged)

 Other Serious or Important 

Medical Events

 Required Intervention to Prevent 

Permanent Impairment/Damage

 Disability or Permanent Damage

 Congenital Anomaly/Birth Defects 

(continued on next page)

Date of death (01-JAN-1900): 
(PREVIOUS EDITION OBSOLETE)

Form FDA-3500A (11/22) Page 2 of 7 (continued on next page)

5. Describe Event or Problem 

6. Relevant Test/Laboratory Data Date (01-JAN-1900) Relevant Test/Laboratory Data Date (01-JAN-1900) 

Additional comments
(PREVIOUS EDITION OBSOLETE)

Form FDA-3500A (11/22) Page 3 of 7 (continued on next page)

7. Other Relevant History, Including Preexisting Medical Conditions (e.g., allergies, pregnancy, tobacco product use, alcohol use, and 

liver/kidney problems, etc.) 

C. SUSPECT PRODUCTS 

SUSPECT PRODUCT #1 

1. Name, Strength, Manufacturer/Compounder 

Product Name Strength Unit 

NDC # or Unique ID Manufacturer/Compounder Name Lot # 

2. List Medical Product and Treatment Given at the Same Time of the Event and Date (Do not include treatment for initial event) 

3. Dose or Amount Frequency Route

Unit Other Frequency Other Route 

4. Treament Dates/Therapy Dates (give best estimate of length of treatment (start/stop) or date of dose reduction.) 

Therapy started on Therapy stopped on Dose Reduced OR Duration Unit 

(e.g., 01-Jan-1900) (e.g., 01-Jan-1900) (e.g., 01-Jan-1900) 

5. Diagnosis for use (indication) 6. Product Type (check all that apply) 7. Expiration Date (e.g., 01-Jan-1900) 

 OTC Generic

 Compounded Biosimilar 

8. Event Abated after use Stopped or Dose Reduced? 9. Event Reappeared after Reintroduction?

 Yes No Doesn’t apply Yes No Doesn’t apply
(PREVIOUS EDITION OBSOLETE)

Form FDA-3500A (11/22) Page 4 of 7 (continued on next page)

SUSPECT PRODUCT #2 

1. Name, Strength, Manufacturer/Compounder 

Product Name Strength Unit 

NDC # or Unique ID Manufacturer/Compounder Name Lot # 

2. List Medical Product and Treatment Given at the Same Time of the Event and Date (Do not include treatment for initial event) 

3. Dose or Amount Frequency Route

Unit Other Frequency Other Route 

4. Treament Dates/Therapy Dates (give best estimate of length of treatment (start/stop) or date of dose reduction.) 

Therapy started on Therapy stopped on Dose Reduced OR Duration Unit 

(e.g., 01-Jan-1900) (e.g., 01-Jan-1900) (e.g., 01-Jan-1900) 

5. Diagnosis for use (indication) 6. Product Type (check all that apply) 7. Expiration Date (e.g., 01-Jan-1900) 

 OTC Generic

 Compounded Biosimilar 

8. Event Abated after use Stopped or Dose Reduced? 9. Event Reappeared after Reintroduction?

 Yes No Doesn’t apply Yes No Doesn’t apply 

D. SUSPECT MEDICAL DEVICE 

1. Brand Name 2a. Common Device Name 2b. Procode 

3. Manufacurer Name, City and State 

4. Model # Lot # Catalog # 

Expiration Date (01-JAN-1900) Serial #
(PREVIOUS EDITION OBSOLETE)

Form FDA-3500A (11/22) Page 5 of 7 (continued on next page)

Unique Device Identifier (UDI) # 

5. Operator of Device 6a. If Implanted, Give Date (01-JAN-1900) 6b. If Explanted, Give Date (01-JAN-1900) 

 Health Professional Patient/Consumer

 Other 

7a. Is this a single-use device that was 7b. If yes, enter the name and address of the reprocessor

reprocessed and reused on a patient?

 Yes No 

8. Was this device ever serviced 9. Is this Device Available for Evaluation? (Do not send to FDA) 

by a third-party servicer?

 Yes No Unknown 

10. Concomitant Medical Products and Therapy Dates (Exclude treatment of event) 

Product Name Therapy Start Date (01-JAN-1900) Therapy End Date (01-JAN-1900) 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

E. INITIAL REPORTER 

1. Name and Address 

Last Name First Name 

Address 

City State/Province/Region ZIP/Postal Code Country 

Phone # Email 

2. Health Professional? 3. Occupation (Select from list) 4. Initial reporter also sent report to FDA

 Yes No Yes No Unknown

Yes No

Returned to manufacturer on (01-JAN-1900) 
(PREVIOUS EDITION OBSOLETE)

Form FDA-3500A (11/22) Page 6 of 7

F. FOR USE BY USER FACILITY/IMPORTER (Devices Only) 

1. Check One 2. User Facility/Importer Report Number 

 User Facility Importer 

3. User Facility or Importer Name/Address 4. Contact Person 5. Phone Number 

6. Date User Facility or Importer 7. Type of Report 

Became Aware of Event (01-JAN-1900) 

8. Date of This Report (01-JAN-1900) 9. Approximate Age of Device 

10. Adverse Event Problem (Refer to coding manual) 

Health Effect – Clinical Code Health Effect – Impact Code Medical Device Problem Code Component Code 

11. Report Sent to FDA? 12. Location Where Event Occurred

(If Yes, enter date (01-JAN-1900)) Ambulatory Surgical Facility Outpatient Treatment Facility Other (Specify) 

 Yes No Home Outpatient Diagnostic Facility

 Hospital Nursing Home

13. Report Sent to Manufacturer? 14. Manufacturer Name/Address 

(If Yes, enter date (01-JAN-1900))

Yes 

No 

G. ALL MANUFACTURERS 

1. Contact Office (and Manufacturing Site for Devices) or Compounding Outsourcing Facility 

Name Email Address Phone Number 

Address 

Compounding Outsourcing Facility 503B? Outsourcing Facility 

 Check box if applicable 

2. Report Source (check all that apply) 3. Date Received by 

 Foreign Literature Health Professional Company Representative Manufacturer (01-JAN-1900) 

 Study Consumer Use Faciltiy Distributor/Importer Other (Please list) 

4. NDA # ANDA # IND # BLA # PMA/510(k) # 

Check all that apply:

 Combination product Pre-ANDA Pre-1938 OTC Compounded Product 

5. If IND/Pre-ANDA, Give Protocol # 6. Type of Report (Check all that apply) 

5-day 15-day Periodic Follow-up # 

7-day 30-day Initial

7. Adverse Event Term(s) 8. Manufacturer Report Number

(continued on next page)
(PREVIOUS EDITION OBSOLETE)

Form FDA-3500A (11/22) Page 7 of 7

H. DEVICE MANUFACTURERS ONLY 

1. Type of Reportable Event (check all that apply.) 2. If Follow-up, What Type? 3. Device Evaluated by Manufacturer?

 Death Malfunction Correction Yes No 

 Serious Injury Summary Report Additional Information 

No. of events summarized Response to FDA Request

 Device Evaluation 

4. Device Manufacture Date (01-JAN-1900) 5. Labeled for Single Use?

 Yes No 

6. Adverse Event Problem (Refer to coding manual) 

Health Effect – Clinical Code Health Effect – Impact Code Medical Device Problem Code Component Code 

Type of Investigation Investigation Findings Investigation Conclusions 

7. If Remedial Action Initiated, Check Type 8. Usage of Device

 Recall Relabeling Patient Monitoring Initial Use of Device

 Repair Notification Modification/Adjustment Reuse

 Replace Inspection Other: Unknown 

9. If action reported to FDA under 21 USC 360i(g), 10. Related Report Number 

list correction/ removal reporting number: 

11. Additional Manufacturer Narrative 

PRIVACY ACT STATEMENT 

Authority: The information collected in this form is provided to comply with the Privacy Act of 1974 (P.L. 93-579) for individuals seeking 

non-employee student, post-graduate or senior scientist training opportunities from the Food and Drug Administration. Purpose and 

Uses: All information collected in this form is required to begin the Traineeship. Completed forms are used by the Staff to meet program 

selection and on-boarding requirements. Information is also shared with the FDA personnel authorized to administer the program. Effects of 

nondisclosure: Disclosure of the information is voluntary; however, collection of this information is necessary to continue with the FDA. 

PRA Info 

This section applies only to requirements of the Paperwork Reduction Act of 1995. 

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* 

The burden time for this collection of information is estimated to average 15 minutes per response, including the time to review instructions, 

search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments 

regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: 

Department of Health and Human Services 

Food and Drug Administration 

Office of Operations 

Paperwork Reduction Act (PRA) Staff 

PRAStaff@fda.hhs.gov 

“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently 

valid OMB control number.”