KHN filed multiple Freedom of Information Act requests over months, and the FDA responded Wednesday saying the data about device malfunctions is now publicly available online.
The FDA reveals that 56,000 malfunctions associated with surgical staplers weren’t reported through its traditional public reporting system.
The Food and Drug Administration allowed one company to send 50,000 reports of harm or malfunctions to an internal database even as patients worried about faulty defibrillators lodged in their hearts.
In the wake of a KHN investigation, the agency will no longer let device makers file reports of harm outside a widely used public database.
In the wake of a KHN investigation, Scott Gottlieb says releasing the records is in the public interest.
For almost two decades, device makers have sent reports of incidents to databases hidden from public view.
The FDA said it might reclassify the widely used devices featured in a recent Kaiser Health News investigation.