Device Events

Madris Kinard, a former FDA manager who founded Device Events, which analyzes FDA data, said it defies belief that Johns Dental never received a complaint worthy of relaying to the FDA.

"That's a red flag for me. If I don't see a single report to the FDA, I typically think there is something going on," Kinard said. "When they don't report, what you have is devices that stay on the market much longer than they should. And patients get harmed."

FDA said it "never" inspected dental lab that made controversial AGGA device Johns Dental Laboratories stopped making the Anterior Growth Guidance Appliance last year after a KFF Health News-CBS News investigation into allegations of patient harm.

Navigating the Challenges in Device Safety: Sens. Dick Durbin and Richard Blumenthal sent a letter noting how the agency missed opportunities to protect the public from faulty medical devices, citing reporting by ProPublica and the Pittsburgh Post-Gazette.

This FDA slide was used by one of their top scientists to describe how many malfunctions can occur before a death or injury report is sent to the FDA. Contact Device Events so we can show you how to identify potentially risky devices that may not yet have caused an injury or death.⁠
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