MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 3MM W ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92126

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an infection and tissue overgrowth at the abutment site.The patient was treated with topical steroid and antibiotics (specific date and duration not reported).

• Brand Name: BIA300 IMPLANT 3MM W 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
• MDR Report Key: 16748658
• MDR Text Key: 313385539
• Report Number: 6000034-2023-01148
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019514
• UDI-Public: (01)09321502019514(10)COH1221036(17)230413
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2023,03/23/2023

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: 04/13/2023
• Device Model Number: 92126
• Device Catalogue Number: 92126
• Device Lot Number: COH1221036
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2023
• Distributor Facility Aware Date: 03/23/2023
• Date Report to Manufacturer: 03/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male