MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM

Model Number 93550

Device Problem Expulsion (2933)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an extrusion of the magnet from the skin. A revision surgery is planned but has not yet taken place at the time of this report.

• Brand Name: BIM400 IMPLANT MAGNET
• 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: 10618264
• MDR Text Key: 209538700
• Report Number: 6000034-2020-02619
• 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

• Type of Report: Initial,Followup
• Report Date: 10/28/2020,10/02/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/01/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: 93550
• Device Catalogue Number: 93550
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2020
• Distributor Facility Aware Date: 10/02/2020
• Event Location: Hospital
• Date Report TO Manufacturer: 10/28/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient TREATMENT DATA

Date Received: 10/01/2020 Patient Sequence Number: 1