MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 POWER SOUNDPROCESSOR, BROWN; COCHLEAR BAHA CONNECT SYSTEM

Model Number	95473
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the clinic, it was reported that the patient was experiencing infections under the processor.

• Brand Name: BAHA 5 POWER SOUNDPROCESSOR, BROWN
• Common Device Name: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 10073487
• Report Number: 6000034-2020-01385
• Device Sequence Number: 2916134
• Product Code: LXB
• UDI-Device Identifier: 09321502034616
• UDI-Public: (01)09321502034616(10)COH1091560(11)161222
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2020
• Report Date (Section F): 05/20/2020

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 Expiration Date: 12/22/2016
• Device Model Number: 95473
• Device Catalogue Number: 95473
• Device Lot Number: COH1091560
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/27/2020
• Event Location: Other
• Date Report to Manufacturer: 05/20/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2020
• 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
• Date Report Sent to FDA: 05/20/2020