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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB SP MAGNET 2 COCHLEAR BAHA ATTRACT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB SP MAGNET 2 COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number 95771
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Erosion (1750); Pain (1994)
Event Type  Injury  
Manufacturer Narrative

This report is filed on november 24, 2016. (b)(4). Implanted device remains.

 
Event Description

Per the clinic, the patient experienced pain and breakdown of skin at magnet site, and was treated with topical and oral antibiotics (date and duration not reported). The issue could not be resolved; subsequently the patient underwent revision surgery to remove the internal magnet. Clinical management is ongoing.

 
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Brand NameSP MAGNET 2
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 AMERICAS
13059 east parkview avenue
centennial CO 80111
Manufacturer Contact
kristel kohne
1 university avenue
macqaurie university, nsw 2109
AS   2109
2 9428 655
MDR Report Key6126581
MDR Text Key60842393
Report Number6000034-2016-02337
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
Report Date 11/08/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/23/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number95771
Device Catalogue Number95771
Device LOT Number112772
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date11/08/2016
Event Location No Information
Date Manufacturer Received11/08/2016
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: 11/23/2016 Patient Sequence Number: 1
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