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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 Appropriate Term/Code Not Available (3191)
Patient Problems Bacterial Infection (1735); Tissue Breakdown (2681)
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Per the patient's surgeon, the patient experienced infection and wound break down at implant site; subsequently the wound had been debrided and the patient underwent skin revision at the site on four separate occasions. The patient was administered antibiotics (date and type not reported). The implanted device remains.

 
Manufacturer Narrative

Per the clinic, the internal magnet was explanted on (b)(6) 2017. The implanted fixture remains insitu.

 
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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
mölnlycke, 43533
SW 43533
Manufacturer Contact
bianca pries
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key6998264
MDR Text Key90929439
Report Number6000034-2017-01962
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 HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/16/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/02/2017
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? No
Event Location No Information
Date Manufacturer Received11/16/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/02/2017 Patient Sequence Number: 1
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