MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92130

Device Problem Insufficient Information (3190)

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on april 01, 2024.

Event Description

Per the clinic, the patient experienced skin overgrowth at the abutment site (date not reported).Subsequently, the patient underwent a skin revision surgery (date not reported).Additional information has been requested but has not been made available as of the date of this report.

• Brand Name: BA300 ABUTMENT 6MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: hemavathi muniesparan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 19009810
• MDR Text Key: 338979031
• Report Number: 6000034-2024-01311
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019552
• UDI-Public: (01)09321502019552(10)COH211802(17)190320
• Combination Product (y/n): N
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2024

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 Expiration Date: 03/20/2019
• Device Model Number: 92130
• Device Catalogue Number: 92130
• Device Lot Number: COH211802
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Sex: Male