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Medical Devices / Inspections and Audits

Saphena Medical Scolded for Late MDR Reporting

Oct. 12, 2018

The FDA smacked Massachusetts specification developer Saphena Medical with a Form 483, after finding the company didn’t submit an MDR for a serious adverse event on time.

Specifically, the company received information of an adverse event involving its Venapax endoscopic device, but did not report it to the FDA within 30 days.

The complaint said the device’s bullet tip fell off during a surgical procedure and had to be removed from the patient through medical intervention.

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