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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 ATTRACT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET; COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number 93550
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Additional information has been requested regarding product brand and model: this information has been made available as of the date of this report.Should further information be provided, a supplementary report shall be submitted.This report is submitted on january 15, 2020.
 
Event Description
Per the clinic, the patient experienced poor magnet retention.The patient had a thinning of the skin flap on an unknown date but still experiences poor magnet retention.Clinical management is ongoing.
 
Manufacturer Narrative
Per the clinic, it was reported that for audiological purposes, the internal magnet was removed in order to convert the patient to a percutaneous baha implant system.An abutment was placed on the implant fixture, which remains insitu.No other event or complications which may have contributed to the decision to convert the patient were reported.This report is submitted on 26 february 2020.
 
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Brand Name
BIM400 IMPLANT MAGNET
Type of Device
COCHLEAR BAHA ATTRACT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
MDR Report Key9589691
MDR Text Key175007065
Report Number6000034-2020-00035
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
PMA/PMN Number
K131240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/15/2020,02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2020
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
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/15/2020
Date Report to Manufacturer12/30/2019
Date Manufacturer Received02/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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