Safety Instructions

19
Reporting adverse events to FDA
MedWatch is the Food and Drug Administration’s (FDA) program for reporting serious reactions,
product quality problems, therapeutic inequivalence/failure, and product use errors with human
medical products, including drugs, biologic products, medical devices, dietary supplements,
infant formula, and cosmetics.
If you think you or someone in your family has experienced a serious reaction to a medical
product, you are encouraged to take the reporting form to your doctor. Your health care provider
can provide clinical information based on your medical record that can help the FDA evaluate
your report. However, we understand that for a variety of reasons, you may not wish to have
the form lled out by your healthcare provider, or your health care provider may choose not
to complete the form. Your health care provider is not required to report to the FDA. In these
situations, you may complete the Online Reporting Form yourself.
You will receive an acknowledgement from the FDA when your report is received. Reports are
reviewed by FDA sta. You will be personally contacted only if we need additional information.
Submitting adverse event reports to FDA
Use one of the methods below to submit voluntary adverse event reports to the FDA: