Breas Medical ABAugust 10, 2022

FDA 483 - Breas Medical AB - August 10, 2022

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Record Details

An FDA inspection of Breas Medical AB, a medical device manufacturer in Molnlycke, Sweden, identified a significant issue with the firm's complaint handling system. The company failed to promptly review, evaluate, and investigate complaints representing Medical Device Reporting (MDR) reportable events. This indicates a potential risk regarding the timely assessment and reporting of adverse events related to their manufactured devices.

Company: Breas Medical AB
Inspection Date: August 10, 2022
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Shannon A. Gregory

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ID · 9f005142-bdd8-483c-a5c6-5a48870ee205