MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU; COCHLEAR BAHA ATTRACT SYSTEM

Model Number ASKU

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2023

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 10, 2023.

Event Description

Per the clinic, the attract magnet was explanted under a general anaesthetic on (b)(6) 2023 so as to improve hearing.The implant remains in-situ.A new site was selected to implant an osia system.

• Brand Name: ASKU
• Type of Device: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvigen 14; molnlycke, 435 3 3; AS 435 33
• MDR Report Key: 17284978
• MDR Text Key: 318642033
• Report Number: 6000034-2023-02270
• Device Sequence Number: 1
• Product Code: LXB
• 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
• Report Date: 07/10/2023,06/16/2023

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 Model Number: ASKU
• 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: 07/10/2023
• Distributor Facility Aware Date: 06/16/2023
• Date Report to Manufacturer: 06/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male