MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 6 MAX, BROWN; COCHLEAR BAHA ATTRACT SYSTEM

Model Number	95204
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, the patient experienced inflammation at the magnet site that was treated with oral and topical antibiotics.The implant remains in-situ.
Additional Manufacturer Narrative
This report is submitted on december 2, 2022.

• Brand Name: BAHA 6 MAX, BROWN
• Common Device Name: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 15902683
• Report Number: 6000034-2022-03612
• Device Sequence Number: 4913335
• Product Code: LXB
• UDI-Device Identifier: 09321502034616
• UDI-Public: (01)09321502034616(10)COH1222692(11)04132018
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2022
• Report Date (Section F): 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 95204
• Device Catalogue Number: 95204
• Device Lot Number: COH1222692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/10/2022
• Date Report to Manufacturer: 11/10/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/02/2022