MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA SOUNDARC; COCHLEAR BAHA CONNECT SYSTEM

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Tissue Breakdown (2681); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on sep 14, 2021.

Event Description

It was reported that the patient experienced skin breakdown on temple areas and was infected (date not reported).Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

Per the clinic, there was no skin breakdown and infection reported for this patient.This report is submitted on october 06, 2021.

• Brand Name: COCHLEAR BAHA SOUNDARC
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 12466002
• MDR Text Key: 271211718
• Report Number: 6000034-2021-02807
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: K171088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention