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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Scar Tissue (2060)

Event Date 08/22/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted september 16, 2019.

Event Description

Per the clinic, the patient experienced skin hypertrophy, thickening and pain at the implant site.Subsequently, revision surgery was performed on (b)(6) 2019, inorder to exchange the abutment.Following revision, the patient was placed on oral antibiotics.

Manufacturer Narrative

During revision surgery on (b)(6) 2019 to replace the abutment it was reported the skin at abutment site was excised, the patient was treated with intra-op iv antibiotics.This report is submitted on 22 april 2020.

• Brand Name: NI
• 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: 9068145
• MDR Text Key: 158769197
• Report Number: 6000034-2019-01923
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2019
• 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
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention