MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB; COCHLEAR BAHA CONNECT SYSTEM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Infection (4544)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an infection at the implant site and was treated with oral and topical antibiotics.Subsequently, the patient was placed under general anesthesia on (b)(6) 2024, in order to excise the skin around the abutment.The orginal abutment was removed during the same procedure and a longer abutment was placed.The implanted device remains.

• Brand Name: NI
• 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: 18872409
• MDR Text Key: 337289228
• Report Number: 6000034-2024-00807
• Device Sequence Number: 1
• Product Code: LXB
• 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: 03/11/2024,02/13/2024

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2024
• Distributor Facility Aware Date: 02/13/2024
• Date Report to Manufacturer: 02/13/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male