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

Model Number ASKU

Device Problem Expulsion (2933)

Patient Problem Skin Infection (4544)

Event Date 10/02/2022

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an infection at the implant site resulting in an extrusion and loss of the magnet.The implant remains in-situ.The infection was treated with topical antibiotics.

Manufacturer Narrative

This report is submitted on january 16, 2023.

• 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
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; 43533 ; SW 43533
• Manufacturer Contact: roberta loveday ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 16172406
• MDR Text Key: 307473605
• Report Number: 6000034-2023-00213
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2022

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
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male