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 Problems Discomfort (2330); Implant Pain (4561)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced pain at the magnet site.The magnet was removed on (b)(6) 2022.The implant remains in-situ.It is unknown if there are plans to re-implant the patient with another magnet.

Manufacturer Narrative

This report is submitted on december 30, 2022.

• 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: 16076014
• MDR Text Key: 306404919
• Report Number: 6000034-2022-03913
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2022,12/07/2022

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: 12/30/2022
• Distributor Facility Aware Date: 12/07/2022
• Date Report to Manufacturer: 12/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female