DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Food and Drug Administration

MEDWATCH

Consumer Voluntary Reporting

(FORM FDA 3500B)

Form Approved: OMB No. 0910-0291

Expiration Date: 06/30/2025

(See PRA Statement below)

When do I use this form?

• You were hurt or had a bad side effect (including new 

or worsening symptoms) after taking a drug or using a 

medical device or product.

• You used a drug, product, or medical device incorrectly 

which could have or led to unsafe use.

• You noticed a problem with the quality of the drug, 

product or medical device.

• You had problems with how a drug worked after 

switching from one maker to another maker.

Don’t use this form to report:

• Vaccines – report problems to the Vaccine Adverse 

Event Reporting System (VAERS).

• Investigational drugs or medical devices (those being 

studied) – report problems to your doctor or to the 

contact person listed in the clinical trial.

• 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, cosmetic or dietary supplement products – report 

problems to the SRP https://www.safetyreporting.hhs.gov/

SRP2.

Will the information I report be kept private?

The FDA recognizes that privacy is an important concern, 

so you should know:

• We ask only for the name and contact information of the 

person filling out the form in case we need more 

information.

• Your name and contact information may be shared 

with the company that makes the product to help them 

better understand the problem you are reporting, 

unless you request otherwise (see Section F).

What types of products should I use this form 

for?

• Prescription and over-the-counter drugs, therapeutic 

biologics and biosimilars including monoclonal 

antibodies, and biologics, such as human cells and 

tissues used for transplantation (for example, tendons, 

ligaments, and bone) allergenics and gene therapies.

• Medical devices, including any health-related kit, test, 

tool, or piece of equipment (such as breast implants, 

pacemakers, diabetes glucose-test kits, hearing aids, 

breast pumps, and many others)

• Cosmetics such as moisturizers, makeup, shampoos 

and conditioners, face and body washes, deodorants, 

nail care products, hair dyes and relaxers, and tattoos

• Foods (including beverages and ingredients added to 

foods)

Are there specific instructions for filling out the 

form?

• Fill in as much information as possible and send in the 

report even if you do not have all the information.

• You can fill out this form yourself or have someone fill it 

out for you. If you need help, you may want to talk with 

your health professional.

• Feel free to include or attach an image of the product. 

Please do not send the products to the FDA.

How will I know the FDA has received my form?

• You will receive a reply from the FDA after we receive 

your report. We will personally contact you only if we 

need additional information.

• Your report will become part of a database so that it can 

be reviewed and compared to other reports by an FDA 

safety evaluator who will determine what steps to take.

How can I contact the FDA if I have questions?

Toll-free line: 1-800-332-1088 

To report online: www.fda.gov/medwatch/report.htm

The information below applies only to requirements of the Paperwork Reduction Act of 1995. 

The burden time for this collection of information is estimated to average 30 

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 the address to the right:

OMB Statement: “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 number.”

Department of Health and Human Services 

Food and Drug Administration 

Office of Chief Information Officer 

Paperwork Reduction Act (PRA) Staff 

PRAStaff@fda.hhs.gov

DO NOT SEND YOUR COMPLETED FORM 

TO THIS PRA STAFF ADDRESS.

FORM FDA 3500B (11/22) MedWatch Consumer Voluntary Reporting General Information Page

 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Food and Drug Administration

MEDWATCH

Consumer Voluntary Reporting

(FORM FDA 3500B)

Form Approved: OMB No. 0910-0291

Expiration Date: 06/30/2025

(See PRA Statement on preceding 

general information page)

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.

Section A – About the Problem

1. What kind of problem was it? (Check all that apply)

Were hurt or had a bad side effect (including new or 

worsening symptoms)

Used a product incorrectly which could have or led to a 

problem

Noticed a problem with the quality of the product

Had problems after switching from one product maker 

to another maker

2. Did any of the following happen? (Check all that apply)

Hospitalization – admitted or stayed longer

Required help to prevent permanent harm 

Disability or health problem

Birth defect

Life-threatening

Death (include date) (e.g., 01-Jan-1900):

Other serious/important medical incident 3. Date the problem occurred (e.g., 01-Jan-1900)

4. Tell us what happened, how it happened or why it happened. (Include as many details as possible. FDA may reach out to you 

for any additional documents if necessary) Characters Remaining (max. 4,000):

For more information, visit http://www.fda.gov/MedWatch Submission of a report does not constitute an admission that medical 

personnel or the product caused or contributed to the event.

FORM FDA 3500B (11/22) MedWatch Consumer Voluntary Reporting Page 1 of 5

 EF
5. Relevant Tests/Laboratory Results Date 

(e.g., 01-Jan-1900) Relevant Tests/Laboratory Results Date 

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

Additional Comments Characters Remaining (max. 2,000):

Section B – Product Availability

1. Do you still have the product in case we need to 

evaluate it? (Do not send the product to FDA. 

We will contact you directly if we need it.)

Yes

No

2. Do you have a picture of the product? (check yes if you are including 

a picture)

Yes

For a problem with a product, including

• prescription or over-the-counter medicine

• biologics, such as blood transfusions, gene therapies, and human 

cells and tissue transplants (for example, tendons, bone, and corneas) 

• nutrition products, such as vitamins and minerals, 

herbal remedies, infant formulas, and medical foods

• cosmetics or make-up products

• foods (including beverages and ingredients added to foods)



For a problem with a medical device, including

• any health-related test, tool, or piece of equipment

• health-related kits, such as glucose monitoring kits 

or blood pressure cuffs

• implants, such as breast implants, pacemakers, or catheters

• other consumer health products, such as contact lenses, hearing aids, 

and breast pumps

 (Skip Section C)

For a health or product problem with a food, cosmetic, dietary supplement 

or tobacco product  Go to https://www.safetyreporting.

hhs.gov/SRP2

Section C – About the Products

1. This report is about Cosmetic Dietary Supplement Food/Medical Food Other

2. Name(s) of the product as it appears on the box, bottle, or package (Include as many names as you see)

3. Check if therapy is on-going

4. Name(s) of the company that makes (or compounds) the product

For more information, visit http://www.fda.gov/MedWatch Submission of a report does not constitute an admission that medical 

personnel or the product caused or contributed to the event.

FORM FDA 3500B (11/22) MedWatch Consumer Voluntary Reporting Page 2 of 5
5. Product Type (check all that apply)

Over-the-Counter Compounded by a Pharmacy or 

an Outsourcing Facility

Generic Biosimilar

6. Expiration date (e.g., 01-Jan-1900) 7. Lot number 8. NDC number

9. Strength (for example, 800mg/160 mg or 20 mg)

10. Quantity (for example, 2 pills, 2 puffs, 

or 1 teaspoon, etc.)

11. Frequency (for example, 

twice daily or at bedtime)

12. How was it taken or used (for example, 

by mouth, injection, or on the skin)?

13a. Date the person first started taking or 

using the product (e.g., 01-Jan-1900):

13b. Date the person stopped taking or 

using the product (e.g., 01-Jan-1900):

13c. Date the person reduced dose of the 

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

14. Give best estimate of duration Unit

15. Why was the person using the product? (such as, what condition 

was it supposed to treat)

16. Did the problem stop after the 

person reduced the dose or stopped 

taking or using the product? Yes No

17. Did the problem return if the person started taking or 

using the product again?

Yes No Didn’t restart

Go to Section E (Skip Section D)

Section D – About the Medical Device

1. Name of medical device

2. Name of the company that makes the medical device

3. Model number 4. Catalog number 5. Lot number 6. Serial number

7. Unique Device Identifier (UDI) number

8. Expiration date

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

9. Was someone operating the 

medical device when the 

problem occurred?

Yes No

If yes, who was operating it?

The person who had the problem A health professional (such as a 

doctor, nurse, or aide) Someone else (Please explain who)

10. For implanted medical devices ONLY (such as pacemakers, breast implants, etc.)

Date the implant was put in (e.g., 01-Jan-1900) Date the implant was taken out (If relevant) (e.g., 01-Jan-1900)

Go to Section E

For more information, visit http://www.fda.gov/MedWatch Submission of a report does not constitute an admission that medical 

personnel or the product caused or contributed to the event.

FORM FDA 3500B (11/22) MedWatch Consumer Voluntary Reporting Page 3 of 5
Section E – About the Person Who Had the Problem

1. Person’s 

Initials

2a. Sex: Enter the patient's sex at birth 

(the sex that a person has or was 

assigned to at birth).

Male Female

Undifferentiated 

Decline to answer

2b. Gender: Enter the patient’s current gender (how the patient thinks of themself).

Cisgender man/boy (gender 

corresponds with birth sex)

Cisgender woman/girl (gender 

corresponds with birth sex)

Transgender man/trans man/ 

female-to-male (FTM)

Transgender woman/trans 

woman/ male-to-female (MTF)

Other gender category; 

please specify: 

Decline to answer

3. Age (specify unit of time for age)

Year(s)

Month(s)

Week(s)

Day(s)

4. Date of Birth (e.g., 01-Jan-1900) 5. Weight (Specify lbs or kg)

lb

kg

6. Ethnicity (Choose only one)

Hispanic/Latino

Not Hispanic/Latino

7. Race (Choose all that apply)

American Indian or Alaska Native

Asian

Black or African American

Native Hawaiian or Other Pacific Islander 

White

8. List known medical conditions. (Such as diabetes, high blood pressure, cancer, heart 

disease, or others) Characters Remaining (max. 2,000):

9. Please list all allergies (such as to drugs, foods, pollen or others)

10. List any other important information about the person (such as tobacco product use, pregnancy, alcohol use, etc.)

11. List all current prescription medications and medical devices being used. Characters Remaining (max. 2,000):

For more information, visit http://www.fda.gov/MedWatch Submission of a report does not constitute an admission that medical 

personnel or the product caused or contributed to the event.

FORM FDA 3500B (11/22) MedWatch Consumer Voluntary Reporting Page 4 of 5
12. List all over-the-counter medications and any vitamins, minerals, supplements, 

and herbal remedies being used. Characters Remaining (max. 2,000):

 Go to Section F

Section F – About the Person Filling Out This Form

We will contact you only if we need additional information.

1. Last name 2. First name

3. Number/Street 4. City and State/Province

5. ZIP or Postal code 6. Country

7. Telephone number 8. Email address 9. Today’s date (e.g., 01-Jan-1900)

10. Did you report this problem to the company that makes the product (the manufacturer/compounder)? Yes No

11. If you do NOT want your identity disclosed to the manufacturer, place an "X" in this box: 

Send This Report by Mail or Fax

Keep the product in case the FDA wants to contact you for more information. Please do not send products to the FDA. 

Mail or fax the form to: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852; FAX: 

800-332-0178 (toll-free).

Thank you for helping us protect the public health.

For more information, visit http://www.fda.gov/MedWatch Submission of a report does not constitute an admission that medical 

personnel or the product caused or contributed to the event.

FORM FDA 3500B (11/22) MedWatch Consumer Voluntary Reporting Page 5 of 5