Form FDA 3500 FDA 3500 FDA Medwatch Consumer Reporting Form

MEDWATCH CONSUMER REPORTING FORM 3500
Report a Problem Caused by a Medical Product
When do I use this form?
• You had a sudden or unsafe effect (including new or
worsening symptoms) after taking a drug or using
a device or product.
• Due to a confusing label or instructions, you used a
drug, product, or device incorrectly, which could have
or did cause harm.
• There is a problem with the quality of the drug,
product or 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 (drugs being studied, not yet
approved) – report problems to your doctor or to the
contact person listed in the clinical trial
• Food – report problems to your local county
department of health
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 so that we may contact
them if we need more information. This information
may be shared with the company that makes the
product to help them evaluate the problem you are
reporting, unless you request otherwise (see
Section E).

What types of products should I use this form for?
• Drugs, including prescription or over-the-counter
medications
• 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)
• Dietary supplements including vitamins and
minerals, herbal remedies, infant formulas, medical
foods, such as those labeled for people with a
specific disease or condition
• Tobacco Products, including those to help you quit
• Cosmetics or Make-up Products
Are there specific instructions for filling out
the form?
• You can fill out this form yourself or have someone fill
it out for you. If you need help, you may want talk with
your health professional.
• Please do not send medical records, drugs, or other
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.

Who can I call if I have questions?
Call the FDA’s MedWatch toll-free line: 800-332-1088.

MEDWATCH CONSUMER REPORTING FORM 3500
Report a Problem Caused by a Medical Product
Section A – About the Problem
What kind of problem was it? (Check all that apply)






Had a sudden or unsafe side effect (including new or worsening symptoms)
Used a drug, product, or device incorrectly due to a confusing label or instructions
Noticed a problem with the quality of the drug, product or device
Had problems after switching from one drug or product maker to another maker

How bad was the problem? (Check all that apply)









Admitted to the hospital
Required help to prevent permanent harm
Caused long term serious disability or health problem
Caused birth defect
Life-threatening
Caused death (mm/dd/yyyy):
Other serious/important medical incident (please list):

Date the problem occurred (mm/dd/yyyy):
Tell us what happened (Include as many details as possible, such as how the person felt or what they noticed after
taking or using the product, any signs and symptoms, and what happened as a result of the problem. (Please do not
send medical records or the product to the FDA.):

For problems caused by a product, including
•
•
•
•
•

prescription or over-the-counter medicine
dietary supplements, such as vitamins
and minerals, herbal remedies, infant formulas, and medical foods
tobacco products, including those to help you quit
cosmetics or make-up products

Go to Section B

For problems caused by a device, including
•
•
•
•

any health-related test, tool, or piece of equipment
health-related kits, such as glucose monitoring kits
implants, such as breast implants, pacemakers, or catheters
other consumer health products, such as contact lenses, hearing aids,
and breast pumps

For more information visit http://www.fda.gov/Safety/MedWatch/default.htm

Go to Section C
(Skip Section B)

MedWatch Consumer Reporting Form Page Page 1 of 3

Section B – About the Product
Name of the product as it appears on the box, bottle, or package (include as many names as you see):
Name of the company that makes the product (if you know it):
What does the product look like (if it is a pill or capsule, list the color and any numbers or letters imprinted on it)?:

Expiration Date (mm/dd/yyyy):
Strength
(250 mg, 1g, etc)

Quantity
(2 pills, 2 puffs, etc)

Frequency
(twice daily, at bedtime, etc)

How was it taken or used
(by mouth, injection, etc)

Date the person first started taking or using the product (mm/dd/yyyy):
Date the person stopped taking or using the product (mm/dd/yyyy):
Why was the person using the product (such as why it was prescribed)?

Did the problem stop after the person stopped taking or using the product?  Yes  No
If the person started taking or using the product again, did the problem return?  Yes  No  Didn’t restart
Go to Section D (skip section C)

Section C – About the Device
Name of the device:
Name of the company that makes the device (if you know it):
Other identifying information (the model, catalog, lot, or serial number, and the expiration date, if you can
locate them):

Was someone operating the device:  Yes  No
If yes, who was using it?

 The person who had the problem
 A health professional (such as a doctor, nurse, or aide)
 Someone else (please explain who):
For implanted devices ONLY (such as pacemakers, breast implants, etc.):
Date implant was put in:
Date implant was taken out (if relevant):
Go to Section D
For more information visit http://www.fda.gov/Safety/MedWatch/default.htm

MedWatch Consumer Reporting Form Page Page 2 of 3

Section D – About the Person Who Had the Problem
Person’s
Initials

Age

Sex

Birth Date
(mm/dd/yyyy)

 Female
 Male

Weight
lbs or kg

or

List known medical problems (such as diabetes, high blood pressure, cancer, heart disease, or others):
List allergies (such as drugs, foods, pollen or others):
List any other important information (such as smoking, pregnancy, alcohol use, etc):
List all current prescription and over-the-counter medications, and any vitamins, minerals, and herbal remedies:

Go to Section E

Section E – About the Person Filling Out This Form
We will contact you only if we need additional information.
Last name:

First name:

Number/Street:

City/State:

Telephone:

Email:

Zip Code:

May we give your name and contact information to the company that makes the product (manufacturer) to help them
evaluate the product?  Yes  No
Did you report this problem to any of the following:
 Your doctor’s office or pharmacy

 Company that makes the product

 Other, please list:
Date of this report (mm/dd/yyyy):

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

Fax:
800-332-0178 (toll-free)
For more information:
Visit us at http://www.fda.gov/MedWatch
Call us at 800-332-1088 (toll-free)

How did you learn about this form?
Thank you for helping us protect the public health.
For more information visit http://www.fda.gov/Safety/MedWatch/default.htm

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