More than 1 Million Medical Device Injury Reports Hidden in FDA Database

More than 1 Million Medical Device Injury Reports Hidden in FDA Database

More than a million adverse events related to medical devices have been hidden in an FDA database not accessible to the public, according to a new report.

Kaiser Health News says that since 2016, at least 1.1 million reports have been put into an “alternative summary reporting” repository rather than a public database called MAUDE (Manufacturer and User Facility Device Experience).

According to Kaiser, the hidden databases has report on around 100 medical devices, including those implanted in individuals. Some of them are surgical staplers, breathing machines and balloon pumps inserted into blood vessels to improve circulation.

An FDA spokesperson told Kaiser that the summary database is designed for issues that are “well-known and well-documented with the FDA.” If a device in this database has the same malfunction multiple times, it is only recorded once, as opposed to each individual time in the MAUDE database.

The spokesperson also said that any device maker can request an exemption from reporting requirements so that reports are placed in the summary database.

FDA records Kaiser reviewed found more than 480,000 injuries or malfunction were put into the summary database just in 2017. In addition, there are over a million reports over a 15-year period that are in this database, which only the FDA has access to. The public can get access to the database through a Freedom of Information request, though you may wait up to two years to hear back.


Jonathan Block

Jonathan Block

Jonathan Block is MedShadow's content editor. He has previously worked for Psychiatry Advisor, Modern Healthcare, Health Reform Week and The Pink Sheet.


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