The content discusses the tragic death of Carlton “PeeWee” Gautney Jr., who died from an insulin pump malfunction. The pump, which was part of a recall, was manufactured by Medtronic and allegedly dispensed a fatal overdose of insulin. The investigation also highlights other cases of medical device malfunctions, including artificial knee and hip implants that caused injuries, and the FDA’s 510(k) clearance which critics argue is not sufficient to ensure patient safety. Medtronic is currently facing multiple lawsuits from injured patients and their families, while the FDA continues to stand by the merits of the 510(k) program despite ongoing concerns about its effectiveness.
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Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records
