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

Model Number ASKU

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Implant Pain (4561)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on february 15, 2022.

Event Description

Per the surgeon, over the past year she has reported chronic pain in the implant area which has been unresponsive to several courses of antibiotics (mode of administration is unknown) and steroid injections at the site of the pain.There are plans to explant the magnet.The implant remains in-situ.

• Brand Name: ASKU
• Type of Device: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 13529833
• MDR Text Key: 285600924
• Report Number: 6000034-2022-00418
• 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: 02/15/2022,01/24/2022

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: 02/15/2022
• Distributor Facility Aware Date: 01/24/2022
• Date Report to Manufacturer: 01/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2022
• 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: Female