MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92128

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Scar Tissue (2060)

Event Date 11/18/2020

Event Type  Injury  

Event Description

Per the clinic, the patient developed hypertrophic scarring at the implant site.The patient, was placed under general anaesthesia on (b)(6) 2020 in order to revise the skin, and was treated with a steroid injection and topical antibiotic ointment.The implanted device remains.

• Brand Name: BI300 IMPLANT 3MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 43522 ; SW 43522
• MDR Report Key: 11183271
• MDR Text Key: 227471665
• Report Number: 6000034-2021-00097
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019538
• UDI-Public: (01)09321502019538(10)176244(17)200831
• 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: 01/18/2021,12/28/2020

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: 08/31/2020
• Device Model Number: 92128
• Device Catalogue Number: 92128
• Device Lot Number: 176244
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2021
• Distributor Facility Aware Date: 12/28/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR