MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92128

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Skin Inflammation/ Irritation (4545)

Event Date 03/31/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 12, 2021.

Event Description

Per the clinic, the patient experienced recurrent skin issues, including inflammation and erythema, at the abutment site, and was treated with topical antibiotic ointment on (b)(6) 2020.However, the issue could not be resolved.A revision surgery is planned but has not yet occurred as of the date of this report.

Manufacturer Narrative

It was reported the patient was placed under general anaesthesia to undergo skin revision surgery on (b)(6) 2021, the abutment was removed.This report is submitted on 12 february 2021.

• Brand Name: BI300 IMPLANT 3MM
• 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
• MDR Report Key: 11152914
• MDR Text Key: 226226054
• Report Number: 6000034-2021-00193
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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
• Device Model Number: 92128
• Device Catalogue Number: 92128
• Device Lot Number: COH88449
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR