MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 9MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92346

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Scar Tissue (2060); Discomfort (2330)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced discomfort and skin redundancy at the abutment site.The patient underwent a procedure (specific date not reported) for a resection of the redundant scar tissue, and a soft tissue reduction.The implanted device remains.

• Brand Name: BIA300 IMPLANT 4MM W ABUTMENT 9MM
• 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: 11510062
• MDR Text Key: 240562744
• Report Number: 6000034-2021-00931
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019767
• UDI-Public: (01)09321502019767(10)95542(17)161130
• 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: 03/18/2021,02/16/2021

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: 11/30/2016
• Device Model Number: 92346
• Device Catalogue Number: 92346
• Device Lot Number: 95542
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2021
• Distributor Facility Aware Date: 02/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention