Reporting System Comparison Table

Reporting System Name Description/Functionality For More Information:
Medical Device Reporting (MDR) Mandatory reporters (i.e., manufacturers, device user facilities, and importers) are required to submit certain types of reports for adverse events and product problems to the FDA about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.
MedWatch The FDA Safety Information and Adverse Event Reporting Program. The system:

  • collects reports of adverse reactions and quality problems, primarily with drugs and medical devices, but also for other FDA-regulated products
  • Voluntary reporting by healthcare professionals, consumers, and patients is conducted on a single, one-page reporting form (Form FDA 3500).
  • is intended to detect safety hazard signals for medical products, enabling the FDA to issue medical product safety alerts or order product recalls, withdrawals, or labeling changes to protect the public health.
MedSun The FDA adverse event reporting program. The system:

  • serves as a powerful two-way channel of communication between CDRH and the clinical community.
  • is Internet-based and designed to be an easy and secure way to report adverse medical device events.

MedSun Subnetworks include:
HeartNet: Focuses on identifying, understanding, and solving problems with medical devices used in electrophysiology laboratories.

KidNet: Focuses on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric intensive care units.
MAUDE MAUDE 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 21CFR 803.19.