MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93333

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Skin Infection (4544)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an infection (specific date not reported) at the abutment site and subsequently, was treated with an antibiotic (specific type and duration not reported).

Event Description

Per the clinic, the patient underwent revision surgery (specific date not reported) to remove the skin.The implanted device remains.Additional information has been requested but it has not been made available as of the date of this report.

Manufacturer Narrative

This report is submitted on jun 6, 2022.

Event Description

It is now reported that the patient was administered oral steroids.

Event Description

Per the clinic, the patient was placed under general anesthesia on (b)(6) 2022 to remove the abutment.

• Brand Name: BA400 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: 13897291
• MDR Text Key: 287887996
• Report Number: 6000034-2022-00868
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/21/2022,10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 93333
• Device Catalogue Number: 93333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2022
• Distributor Facility Aware Date: 10/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female