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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA ATTACT SYSTEM LXB

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COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA ATTACT SYSTEM LXB Back to Search Results
Model Number BIM400
Device Problem Extrusion (2934)
Patient Problems Bacterial Infection (1735); Necrosis Of Flap Tissue (1972)
Event Date 05/09/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). This report is filed on august 18, 2016 by cochlear limited on behalf of cochlear americas. Implanted device remains.

 
Event Description

Per the clinic, the patient experienced extrusion of the magnet and necrosis of the skin flap. Subsequently the magnet was explanted on (b)(6) 2016 and the patient was treated with topical and oral antibiotics (date not reported). The implanted device remains.

 
Manufacturer Narrative

Correction: the correct brand name is cochlear baha attact system and pma is k131240 not flange fixture and abutment and pma k100360 as previously reported. This report is filed on october 10, 2016.

 
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Brand NameCOCHLEAR BAHA ATTACT SYSTEM
Type of DeviceLXB
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
Manufacturer (Section G)
COCHLEAR AMERICAS
13059 east peakview avenue
centennial 80111
Manufacturer Contact
kristel kohne
1 university avenue
macquarie university, nsw 2109
AS   2109
2 9428 655
MDR Report Key5884906
MDR Text Key52380029
Report Number6000034-2016-01675
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 08/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberBIM400
Device Catalogue Number93550
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date08/06/2016
Event Location No Information
Date Manufacturer Received08/06/2016
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 Initial

Patient TREATMENT DATA
Date Received: 08/17/2016 Patient Sequence Number: 1
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