Medical Device Reporting
The U.S. Food and Drug Administration (FDA) relies on voluntary reporting of serious adverse events, product problems, or medication errors that are suspected to be associated with the use of an FDA-regulated drug, biologic, device, or dietary supplement. The FDA uses this information to maintain the safety surveillance of these products and devices. Data may serve as the critical action that prompts a modification in use or design of a product or device, improves the safety profile of the drug or device and leads to increased patient safety.
|Advice about voluntary reporting|
|Product problems – quality, performance or safety concerns||
|Serious adverse event||An event is serious when patient outcome is:
|Report even if||
|* Adapted from directions of MedWatch 3500 Voluntary Reporting Form|
Adverse events and side effects that occur after the administration of U.S. licensed vaccines are reported to VAERS, a cooperative program for vaccine safety of the FDA and the Centers for Disease Control and Prevention (CDC).
Report post-vaccination adverse events on-line at: http://vaers.hhs.gov
Under the requirements of the Safe Medical Device Act, user-facilities such as hospitals and nursing homes are legally required to report suspected medical device-related deaths to both FDA and the manufacturer, if known, and serious injuries to the manufacturer or to FDA, if the manufacturer is unknown. These reports must be made on the MedWatch 3500A Mandatory Reporting Form. Completed forms must be submitted to the FDA. There is no on-line or electronic submission for the FDA MedWatch 3500A mandatory form at this time.
Download 3500A Mandatory reporting form (.pdf) (54 KB)
The FDA’s MAUDE opens in a new tab data represents reports of adverse events involving medical devices. The download data files consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. The searchable database data contains the last 10 year’s data. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19 opens in a new tab.
An on-line search opens in a new tab is available which allows you to search the CDRH’s database information on medical devices which may have malfunctioned or caused a death or serious injury.
MedSun is a newsletter-based Web site which provides monthly updates about timely medical device issues that may impact patient safety. The site provides public access to adverse event reports submitted by 350 healthcare facility participants. These reports are associated with patient injuries or potential for harm events and the site also provides educational programs to learn about the identification and analysis of device problems.