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

Device Problem Expulsion (2933)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 29, 2020.

Event Description

Per the patient, she experienced a protrusion of the internal magnet through the skin.The implant remains in-situ.

Event Description

It was reported that the internal magnet was explanted due to infection and extrusion at site.Clinical management is ongoing.

Manufacturer Narrative

It was reported that the internal magnet was explanted due to infection and extrusion at site.Clinical management is ongoing.This report is submitted on 26 august 2020.

• 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: 10099849
• MDR Text Key: 193007729
• Report Number: 6000034-2020-01387
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 08/26/2020,08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2020
• Distributor Facility Aware Date: 08/03/2020
• Date Report to Manufacturer: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention