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 Drug Resistant Bacterial Infection (4553)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 3, 2022.

Event Description

Per the surgeon, the patient experienced a skin infection (b)(6) at the abutment site which was treated with an oral antibiotic.The implant remains in-situ.

• 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 2 2; SW 435 22
• MDR Report Key: 14274921
• MDR Text Key: 290698296
• Report Number: 6000034-2022-01233
• Device Sequence Number: 1
• Product Code: MAH
• UDI-Device Identifier: 09321502022712
• UDI-Public: (01)09321502022712(11)07052019(17)06182024
• 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: Physician
• Type of Report: Initial
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 93331
• Device Catalogue Number: 93331
• Device Lot Number: COH1317192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female