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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 93550
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Wound Dehiscence (1154); Fluid Discharge (2686)
Event Type  Injury  
Event Description
Per the clinic, it was reported that the patient experienced a wound dehiscence of the incision line subsequent to the formation of a fistula formation at the implant site.Subsequently, magnet removal surgery was scheduled for (b)(6) 2020.It is unknown whether the surgery has taken place, as of the date of this report.
 
Event Description
It was reported that the magnet was explanted under a general anaesthetic on (b)(6) 2020 under a general anaesthetic.The implant remains in-situ.
 
Manufacturer Narrative
It was reported that the magnet was explanted under a general anaesthetic on (b)(6) 2020 under a general anaesthetic.The implant remains in-situ.This report is submitted on march 17, 2020.
 
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Brand Name
BIM400 IMPLANT MAGNET
Type of Device
COCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
MDR Report Key9881531
MDR Text Key185944797
Report Number6000034-2020-00855
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 04/17/2020,03/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2020
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 FDA04/17/2020
Distributor Facility Aware Date03/02/2020
Event Location Hospital
Date Report to Manufacturer03/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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