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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 Problem Extrusion (2934)
Patient Problem Skin Erosion (2075)
Event Type  Injury  
Manufacturer Narrative

This report is submitted by cochlear limited (manufacturer) on behalf of cochlear americas. (b)(4). This report is filed october 5, 2016. Implanted device remains.

 
Event Description

Per the clinic, the patient experienced skin flap breakdown resulting in the extrusion of the device. Subsequently, the patient was treated with topical antibiotics. There are plans to explant the magnet and close the implant site; however, this has not occurred as of the date of this report, (b)(6) 2016.

 
Manufacturer Narrative

Correction: the correct model number is: 93550; the correct catalog # is: 93550; the correct lot # is: 107243; the correct brand name is: bim400 implant magnet. Per the patient's audiologist, the patient underwent revision surgery on (b)(6) 2016, to remove the internal magnet. During the procedure, an abutment was placed on the fixture. This report is submitted january 18, 2017.

 
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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 33,
SW
Manufacturer (Section G)
COCHLEAR AMERICAS
13059 east peakview avenue
centennial, co 80111, us
Manufacturer Contact
bianca hanlon
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key5998905
MDR Text Key56441910
Report Number6000034-2016-01951
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK131240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation AUDIOLOGIST
Type of Report Initial,Followup
Report Date 12/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/04/2016
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
Device LOT Number107243
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date09/16/2016
Event Location No Information
Date Manufacturer Received12/06/2016
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: 10/04/2016 Patient Sequence Number: 1
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