MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93336

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

Patient Problem Skin Infection (4544)

Event Date 05/05/2022

Event Type  Injury  

Manufacturer Narrative

This report is submitted on june 14, 2022.

Event Description

Per the clinic, the patient experienced an infection at the abutment site that was treated with oral and topical antibiotics.

Event Description

Per the clinic, the patient underwent a skin revision surgery under general anesthesia on (b)(6) 2022 in order to remove the affected tissue and to have the existing abutment replaced with a new one.

• Brand Name: BA400 ABUTMENT 12MM
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 14682406
• MDR Text Key: 294053756
• Report Number: 6000034-2022-01669
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2022,07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 93336
• Device Catalogue Number: 93336
• 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: 08/12/2022
• Distributor Facility Aware Date: 07/21/2022
• Date Report to Manufacturer: 07/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male