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The Manufacturer and User Facility Device Experience (MAUDE) database is a searchable database of medical device reports (MDRs) of adverse events involving medical devices over the last...
This page contains information about Manufacturer and User Facility Device Experience (MAUDE) Database reports of adverse events involving medical devices.
The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care...
About MAUDE. Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to...
Information about the Adverse Event Reporting Data Files including Manufacturer and User Facility Device Experience (MAUDE) data and Medical Device Reporting (MDR) data.
The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse...
How is the MAUDE Database Full Text Search Index searched? Because of the amount of MAUDE data, you must select the 2-year period in which to search. Your search term can be the exact name of a...
The openFDA device adverse event API returns data from Manufacturer and User Facility Device Experience (MAUDE), an FDA dataset that contains medical device adverse...
Our search engine for the MAUDE database allows users to apply search criteria such as device type, catalog number, and lot number. It also permits more complex search strategies (for greater search flexibility) and more user-friendly search results, including the ability to save or print all results from a single page.
MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996.