KHN: Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices

KHN: Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices. “The FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions, a Kaiser Health News investigation shows. Since 2016, at least 1.1 million incidents have flowed into the internal ‘alternative summary reporting’ repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.”