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
Additional Manufacturer Narrative
Additional information has been requested; however, not made available as of the date of this report.This report is submitted on may 20, 2020.
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: 10073485
• Report Number: 6000034-2020-01384
• Device Sequence Number: 2916135
• Product Code: LXB
• UDI-Device Identifier: 09321502034616
• UDI-Public: (01)09321502034616(10)COH1091560(11)161222
• Combination Product (Y/N): N
• PMA/510(K) Number: K161123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2020

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2020
• 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