MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 SOUND PROCESSOR, BLACK; COCHLEAR BAHA ATTRACT SYSTEM

Model Number 95202

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on april 10, 2019.(b)(4).

Event Description

It was reported the patient experienced infection at implant site and subsequently was treated with antibiotics (date and type not reported).

Manufacturer Narrative

Per the clinic, it was reported that the patient underwent skin revision surgery on (b)(6) 2019, in order to repair the skin at the implant site.The device remains insitu.This report is submitted august 30, 2019.

• Brand Name: BAHA 5 SOUND PROCESSOR, BLACK
• Type of Device: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 8498029
• MDR Text Key: 141429793
• Report Number: 6000034-2019-00625
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

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
• Device Model Number: 95202
• Device Catalogue Number: 95202
• Device Lot Number: 3010130469784
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention