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 12/22/2021

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an infection at the abutment site that was treated with an antibiotic (oral) and steroids (injection and oral).

Manufacturer Narrative

This report is submitted on june 14, 2022.

• 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 2 2; SW 435 22
• MDR Report Key: 14682404
• MDR Text Key: 294053835
• Report Number: 6000034-2022-01931
• Device Sequence Number: 1
• Product Code: MAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2022

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
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male