FDA 483 - Breas Medical AB - August 10, 2022

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.