MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92129

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Infection (4544)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january, 2022.

Event Description

Per the clinic, the patient experienced an infection (treatment unknown) at the abutment site.The device was explanted (b)(6) 2021.It is unknown if there are plans to re-implant the patient with another device.Further information is being sought from the clinic.

Event Description

Additional information: per the clinic, the patient was placed under general anaesthesia on (b)(6) 2021 during the explant procedure.

• Brand Name: BI300 IMPLANT 4 MM
• 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
• MDR Report Key: 13146237
• MDR Text Key: 283136221
• Report Number: 6000034-2022-00043
• Device Sequence Number: 1
• Product Code: LBX
• UDI-Device Identifier: 09321502019545
• UDI-Public: (01)09321502019545(10)COH1131204(11)10252017(17)08162022
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2022,03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/16/2022
• Device Model Number: 92129
• Device Catalogue Number: 92129
• Device Lot Number: COH1131204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2022
• Distributor Facility Aware Date: 03/09/2022
• Date Report to Manufacturer: 03/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female