MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 RAW ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92119

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 07/14/2022

Event Type  Injury  

Manufacturer Narrative

This report is submitted on sept 12, 2022.

Event Description

Per the clinic, the patient experienced skin overgrowth.There was a skin revision under a general anaesthetic.The implant remains in-situ.

• Brand Name: BA300 RAW ABUTMENT 6MM
• 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: 15398367
• MDR Text Key: 299659241
• Report Number: 6000034-2022-02450
• Device Sequence Number: 1
• Product Code: MAH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2022,08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 92119
• Device Catalogue Number: 92119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2022
• Distributor Facility Aware Date: 08/22/2022
• Date Report to Manufacturer: 08/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male