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Medical Device Reporting

Voluntary reporting by health professionals

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.

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Voluntary form 3500

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.

The FDA Form 3500 should be used by healthcare professionals and consumers for voluntary reporting of adverse events related to products, devices, drugs, or biologics noted in the course of clinical care.
Advice about voluntary reporting
Adverse experiences
  • Medications (drugs or biologics)
  • Medical devices (including in-vitro diagnostics)
  • Special nutritional products (dietary supplements, medical foods, infant formulas)
  • Cosmetics
  • Medication errors
Product problems – quality, performance or safety concerns
  • Suspected counterfeit product
  • Suspected contamination
  • Questionable stability
  • Defective components
  • Poor packaging or labeling
  • Therapeutic failures
Serious adverse event An event is serious when 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
* Adapted from directions of MedWatch 3500 Voluntary Reporting Form

Vaccine Adverse Event Reporting System (VAERS)

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

Mandatory device reporting

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)

FDA's MAUDE database (Manufacturer and User Facility Device Experience database)

The FDA’s MAUDE database represents reports of adverse events involving medical devices which have malfunctioned or caused a death or serious injury. The online searchable database consists of both voluntary and mandatory reports on medical devices received from any source. Voluntary reports have been included since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. The database is updated quarterly by FDA.

http://www.fda.gov/cdrh/maude.html

FDA's MedSun Medical Product Safety Network

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.

http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/default.htm

FDA's Center for Devices and Radiologic Health

Additional information on reporting at FDA Center for Devices and Radiological Health (CDRH)

http://www.fda.gov/cdrh/mdr/