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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number 93550
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Necrosis Of Flap Tissue (1972); Patient Problem/Medical Problem (2688)
Event Date 06/18/2020
Event Type  Injury  
Manufacturer Narrative

This report is submitted on july 14, 2020.

 
Event Description

Per the surgeon, the patient experienced tissue necrosis at the implant magnet site. The patient underwent revision surgery on (b)(6) 2020, to close the skin and remove the internal magnet. The implanted device remains.

 
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Brand NameBIM400 IMPLANT MAGNET
Type of DeviceNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
AS 435 22
Manufacturer Contact
weiting zhen
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key10268784
MDR Text Key198679424
Report Number6000034-2020-01761
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
Type of Report Initial,Followup
Report Date 08/07/2020,07/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number93550
Device Catalogue Number93550
Device LOT NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/07/2020
Event Location No Information
Date Report TO Manufacturer07/16/2020
Date Manufacturer Received06/18/2020
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: 07/13/2020 Patient Sequence Number: 1
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