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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB UNKNOWN COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number UNKNOWN
Device Problem Extrusion (2934)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative

Patient and device details unavailable at the time of this report, this report is submitted on (b)(6) 2017. (b)(4).

 
Event Description

Per the clinic, the patient experienced infection at implant site and extrusion of the magnet. Subsequently the patient was administered oral antibiotics (date and duration not reported). The implanted device remains.

 
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Brand NameUNKNOWN
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 Contact
kristel kohne
1 university avenue
macquarie university, nsw 2109,
AS   2109,
94286555
MDR Report Key6639390
MDR Text Key77497379
Report Number6000034-2017-01102
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeGG
PMA/PMN NumberK131240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 05/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2017
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: 06/14/2017 Patient Sequence Number: 1
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