The MAUDE database houses MDRs submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. Learn More. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers. MAUDE annually captures several hundred thousand medical device reports (MDRs) regarding alleged medical device failures or adverse events. Gathering background research about a product liability issue through publicly available information often leads practitioners to the FDA’s Manufacture and User Facility Device Experience database (MAUDE). MAUDE contains a treasure trove of … MAUDE (Manufacturer and User Facility Device Experience) MAUDE data represents reports of adverse events involving medical devices.

MAUDE data represents reports of adverse events involving medical devices.
1-888-INFO-FDA (1-888-463-6332) Contact FDA Search FDA's Medical Device Adverse Events (MAUDE) 1: Enter Your Medical Device or Company Name Above 2: Press Search Disclaimer. MAUDE data contain reports received by the FDA of adverse events involving medical devices. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.


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