Form Fda 3500 - The Fda Safety Information And Adverse Event Reporting Program (Page 2 of 2) in pdf

ADVICE ABOUT VOLUNTARY REPORTING

Detailed instructions available at:

Report adverse events, product problems or product

Report even if:

. .

use errors with:

You're not certain the product caused the event

. .

You don't have all the details

Medications (drugs or biologics)

. .

Medical devices (including in-vitro diagnostics)

How to report:

. .

Combination products (medication & medical devices)

Just fill in the sections that apply to your report

Human cells, tissues, and cellular and tissue-based

. .

Use section D for all products except medical devices

products

Attach additional pages if needed

Special nutritional products (dietary supplements,

Use a separate form for each patient

medical foods, infant formulas)

Report either to FDA or the manufacturer (or both)

Cosmetics

Other methods of reporting:

. .

Report product problems - quality, performance or

To FAX report

1-800-FDA-0178 --

safety concerns such as:

. .

To report by phone

1-800-FDA-1088 --

Suspected counterfeit product

-- To report online

. .

Suspected contamination

If your report involves a serious adverse event with a

Questionable stability

. .

device and it occurred in a facility outside a doctor's

Defective components

office, that facility may be legally required to report to FDA

Poor packaging or labeling

-Fold Here-

and/or the manufacturer. Please notify the person in that

-Fold Here-

Therapeutic failures (product didn't work)

facility who would handle such reporting.

Report SERIOUS adverse events. An event is serious

If your report involves a serious adverse event with a

when the patient outcome is:

. .

vaccine call 1-800-822-7967 to report.

Death

. .

Life-threatening

Confidentiality: The patient's identity is held in strict

Hospitalization - initial or prolonged

confidence by FDA and protected to the fullest extent of

. .

Disability or permanent damage

the law. FDA will not disclose the reporter's identity in

Congenital anomaly/birth defect

response to a request from the public, pursuant to the

Required intervention to prevent permanent

Freedom of Information Act. The reporter's identity,

impairment or damage

including the identity of a self-reporter, may be shared with

the manufacturer unless requested otherwise.

Other serious (important medical events)

The public reporting burden for this collection of information has been estimated to average 36 minutes per response, including the time for

reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection

of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for

reducing this burden to:

Department of Health and Human Services

Please DO NOT

OMB statement:

Food and Drug Administration - MedWatch

"An agency may not conduct or sponsor, and a

RETURN this form

10903 New Hampshire Avenue

person is not required to respond to, a collection of

to this address.

Building 22, Mail Stop 4447

information unless it displays a currently valid

Silver Spring, MD 20993-0002

OMB control number."

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

FORM FDA 3500 (10/05) (Back)

Please Use Address Provided Below -- Fold in Thirds, Tape and Mail

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UNITED STATES

Food and Drug Administration

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The FDA Safety Information and Adverse Event Reporting Program

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20852-9787

Form Fda 3500 - The Fda Safety Information And Adverse Event Reporting Program Page 2

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