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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.
 
Manufacturer Narrative
During the revision surgery on (b)(6) 2020, there was a skin-flap rotation.An infection was noted that was treated with iv and oral antibiotics.This report is submitted on august 7, 2020.
 
Event Description
During the revision surgery on (b)(6) 2020, there was a skin-flap rotation.An infection was noted that was treated with iv and oral antibiotics.
 
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Brand Name
BIM400 IMPLANT MAGNET
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
AS  435 22
MDR Report Key10268791
MDR Text Key198679583
Report Number6000034-2020-01762
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/07/2020
Distributor Facility Aware Date06/18/2020
Date Report to Manufacturer07/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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