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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number 93550
Device Problems Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 10/16/2020
Event Type  Injury  
Manufacturer Narrative

This report is submitted on november 6, 2020.

 
Event Description

Per the clinic, the patient experienced an extrusion of the magnet through the skin secondary to an infection which was treated with oral and iv antibiotics. The patient was hospitalised and the magnet was explanted under a general anaesthetic on (b)(6) 2020. A cover screw was placed over the implant.

 
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Brand NameBIM400 IMPLANT MAGNET
Type of DeviceCOCHLEAR 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 Key10796543
MDR Text Key215018272
Report Number6000034-2020-02969
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK131240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 10/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number93550
Device Catalogue Number93550
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2020
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 TREATMENT DATA
Date Received: 11/05/2020 Patient Sequence Number: 1
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