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MAUDE - MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE

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Frequently Asked Questions

Can we search for product codes in THE MAUDE database?

The MAUDE database can be used to search adverse events for different product codes. One question came up as I was doing some risk analysis for a particular product code. As part of risk analysis, I was told that we can search for product codes. What does it mean by similar product codes?

What does Maude stand for?

MAUDE - Manufacturer and User Facility Device Experience. 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.

How do I download the Maude data files to a database?

Downloading Hint: When downloading the MAUDE data files to a database such as Microsoft Access, it is recommended that you first open, then save the data file in Microsoft WORD. This will add an "end of record" marker to each MAUDE record that can be recognized by Microsoft ACCESS.

How does the FDA use MDRS in Maude?

The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. The MAUDE database houses MDRs submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities)...


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