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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 95772
Device Problem Extrusion (2934)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Per the surgeon, the patient experienced extrusion of the magnet and subsequently was treated with an oral antibiotic (date and duration not reported). On (b)(6) 2018 the patient underwent a skin revision under a general anaesthetic. There are plans to resume use of the device once the site has healed.

 
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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 BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke 43533
SW 43533
Manufacturer Contact
sujeewa wijesinghe
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key7246792
MDR Text Key99183422
Report Number6000034-2018-00301
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
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 01/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/02/2019
Device MODEL Number95772
Device Catalogue Number95772
Device LOT Number124910
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/22/2018
Was Device Evaluated By Manufacturer? No
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: 02/07/2018 Patient Sequence Number: 1
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