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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA ATTRACT LXB Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

This report is submitted by cochlear limited (manufacturer) on behalf of (b)(4). Registration number 3009092818 and exemption number (b)(4). Implanted device remains.

 
Event Description

Per the clinic, the patient experienced skin breakdown at implant site, however the issue could not be resolved. Subsequently the patient underwent skin revision to remove excess skin and was administered with topical antibiotics (date not reported).

 
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Brand NameCOCHLEAR BAHA ATTRACT
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, co 80111
Manufacturer Contact
kristel kohne
1 university avenue
macqaurie university, nsw 2109
AS   2109
2 9428 655
MDR Report Key5818389
MDR Text Key50287630
Report Number6000034-2016-01457
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
Report Date 07/07/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue Number93564
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date07/07/2016
Event Location No Information
Date Manufacturer Received07/07/2016
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: 07/24/2016 Patient Sequence Number: 1
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