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

Model Number 95473

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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 Description

Per the clinic, it was reported that the patient was experiencing infections under the processor.

• Brand Name: BAHA 5 POWER SOUNDPROCESSOR, BROWN
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; po box 82; molnlycke, 435 2 2; SW 435 22
• Manufacturer Contact: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 10073485
• MDR Text Key: 191666566
• Report Number: 6000034-2020-01384
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502034616
• UDI-Public: (01)09321502034616(10)COH1091560(11)161222
• Combination Product (y/n): N
• PMA/PMN Number: K161123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention