Date: Fri, 29 Dec 2000 01:33:54 -0600 (CST)

This Information below has been copied from a MedWatch form.

MedWatch

The FDA Medical Products Reporting Program

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20852-9787

(Use this address to request forms and to return completed forms.)

Fax - 1-800-FDA-0178

Department of Health and Human Services

Public Health Service

Food and Drug Administration

Rockville, MD 20857

The MedWatch form is for voluntary reporting of adverse events and product problems. MedWatch is the FDA Medical Products Reporting Program

This information is on the back of the form:

Advice About Voluntary Reporting

Report experiences with:

* medications (drugs or biologics)

* medical devices (including in-vitro diagnostics)

* special nutritional products (dietary supplements, medical foods, infant fourmulas)

* other products regulated by FDA

Report SERIOUS adverse events. An event is serious when the patient outcome is:

* death

* life-threatening (real risk of dying)

* hospitalization (initial or prolonged)

* disability (significant, persistent or permanent)

* congenital anomaly

* required intervention to prevent permanent impairment or damage

Report even if:

* you're not certain the product caused the event.

* you don't have all the details

Report product problems - quality, performance or safety concerns such as:

* suspected contamination

* questionable stability

* defective components

* poor packaging or labelling

How to report:

* just fill in the sections (of the form) that apply to your report

* use section C for all products except medical devices

* attach additional blank pages if needed

* use a separate form for each patient

* report either to FDA or the manufacturer (or both)

Important numbers:

* 1-800-FDA-0178 - to FAX report

* 1-800-FDA-7737 - to report by modem

* 1-800-FDA-1088 - for more information or to report quality problems

* 1-800-822-7967 - for a VAERS form for vaccines

If your report involves a serious adverse event with a device and it occurred in a facility outside a doctor's office, that facility may be legally required to report to FDA and/or the manufacturer. Please notify the person in that facility who would handle such reporting.

Confidentiality: The patient's identity is held in strict confidence by FDA and protected to the fullest extent of the law. The reporter's identity may be shared with the manufacturer unless requested otherwise. However, FDA will not disclose the reporter's identity in response to a request from the public, pursuant to the Freedom of Information Act.

Lany