MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 SUPERPOWER PROCESSING UNIT; COCHLEAR BAHA CONNECT SYSTEM

Model Number 96003

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on october 15, 2019.

Event Description

Per the clinic, the patient developed an open wound at the implant site subsequent to wearing the external sound processor in a reverse configuration.The patient was treated with an antibiotic ointment and it was reported that the wound healed following treatment.

• Brand Name: BAHA 5 SUPERPOWER PROCESSING UNIT
• 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 Contact: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 9189358
• MDR Text Key: 163894371
• Report Number: 6000034-2019-02033
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 3010140074445
• UDI-Public: (01)3010140074445(10)COH1255891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 96003
• Device Catalogue Number: 96003
• Device Lot Number: COH1255891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2018
• 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