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# Death Misclassifications in MAUDE Database
- URL: https://www.fdaweb.com/death-misclassifications-in-maude-database/
- Published: 2019-10-09T12:00:00.000Z
- Updated: 2026-09-15T01:55:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145206

Writing in *JAMA Internal Medicine*, researchers say they found a substantial misclassification of patient deaths in the FDA MAUDE (manufacturer and user facility device experience) database for the Sapien 3 and MitraClip devices from their approval dates through 12/31/18\. The [article](https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2752362?ref=fdaweb.com) says the miscategorizations resulted in underreporting of deaths and “raise concerns about the accuracy of adverse event reports for high-risk devices.”

The authors say their results complement news reports indicating that the agency allowed medical device manufacturers to file reports of malfunctions in a hidden database, known as alternative summary reporting.

“Both the miscategorization of deaths in FDA adverse event reporting and hidden adverse event reports can lead to inaccurate public and physician perception of the safety of medical devices and can compromise informed decision-making,” the authors conclude. “Given the increased reliance on postmarketing surveillance, improving the accuracy and clarity of adverse event reporting should be a high priority for both FDA and industry.”