MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 10MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93331

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Infection (4544)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on june 6, 2022.

Event Description

Per the clinic, the patient experienced an infection at the abutment site.The abutment was removed and will be replaced once the infection clears.

Manufacturer Narrative

Per the clinic, the patient was treated with oral and topical antibiotics (specific date and duration not reported).This report is submitted on july 12,2022.

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 10MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; 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: belinder gill ; unit ug-1, vertical podium; no.8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 14599663
• MDR Text Key: 293333647
• Report Number: 6000034-2022-01785
• Device Sequence Number: 1
• Product Code: MAH
• UDI-Device Identifier: 09321502022712
• UDI-Public: (01)09321502022712(10)COH1306446(11)05202019(17)04292024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/29/2024
• Device Model Number: 93331
• Device Catalogue Number: COH1306446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2019
• 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