# FDA 483 - Breas Medical AB - August 10, 2022

Source: https://www.globalkeysolutions.net/records/483/breas-medical-ab/9f005142-bdd8-483c-a5c6-5a48870ee205

> FDA 483 for Breas Medical AB on August 10, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Breas Medical AB
- Inspection Date: 2022-08-10
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Shannon A. Gregory](https://www.globalkeysolutions.net/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

Company: https://www.globalkeysolutions.net/companies/breas-medical-ab/86c4389c-58cf-4b60-a0d8-54a9a8468615

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd