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Form FDA 3500B - MEDWATCH Consumer Voluntary Reporting

1 Form FDA 3500B - MEDWATCH Consumer Voluntary Reporting
2 Form FDA 3500B - MEDWATCH Consumer Voluntary Reporting
3 Form FDA 3500B - MEDWATCH Consumer Voluntary Reporting
4 Form FDA 3500B - MEDWATCH Consumer Voluntary Reporting
5 Form FDA 3500B - MEDWATCH Consumer Voluntary Reporting
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, not yet approved) – report problems to your
doctor or to the contact person listed in the clinical trial
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. This information will not be given out to the
public.
• Information about the problem 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 E).
What types of products should I use this form
for?
• Drugs, including prescription or over-the-counter
medicines, and biologics, such as human cells and
tissues used for transplantation (for example,
tendons, ligaments, and bone) 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)
• Nutrition products, including vitamins and minerals,
herbal remedies, infant formulas, and medical foods,
such as those labeled for people with a specific
disease or condition
• Cosmetics or make-up products
• 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. 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
www.fda.gov/reportinghelp
To report online: www.fda.gov/medwatch/report.htm
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
MEDWATCH Consumer Voluntary Reporting
(FORM FDA 3500B)
FORM FDA 3500B (4/13) General Information Page
MedWatch Consumer Voluntary Reporting
Form Approved: OMB No. 0910-0291
Expiration Date: 6/30/2015
(See PRA Statement below)
EF
The information below applies only to requirements of the Paperwork Reduction Act of 1995.
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
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.”
The burden time for this collection of information is estimated to average 25
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:
DO NOT SEND YOUR COMPLETED FORM
TO THIS PRA STAFF EMAIL ADDRESS.
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