MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93357

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Infection (4544)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on march 04, 2024.

Event Description

Per the clinic, the patient experienced an infection at the abutment site and subsequently was treated with oral and topical antibiotics for 10 days (specific date not reported).The implanted device remains.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

Per the clinic, the patient was placed under general anesthesia on (b)(6) 2024, in order to remove the soft tissue with biopsy punch and to change the abutment.This report is submitted on april 05, 2024.

• Brand Name: BA300 ABUTMENT 12MM
• 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: nurshahqifah latif ; unit ug-1, vertical podium; no. 8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18824926
• MDR Text Key: 336738302
• Report Number: 6000034-2024-00733
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502033435
• UDI-Public: (01)09321502033435(10)COH1349015(17)241203
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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 Model Number: 93357
• Device Catalogue Number: 93357
• Device Lot Number: COH1349015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 04/05/2024
• 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: Female