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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 Patient Device Interaction Problem (4001)
Patient Problem Increased Sensitivity (4538)
Event Date 01/18/2021
Event Type  Injury  
Event Description

Per the clinic, the patient experienced issues with sensitivity and retention at the implant magnet site, following a previous soft tissue reduction (specific date not reported). The patient was placed under general anesthesia on (b)(6) 2021, in order to convert the patient to a transcutaneous osia implant system. During the procedure, the abutment was removed and an implant was placed on the internal fixture.

 
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Brand NameBIM400 IMPLANT MAGNET
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
MDR Report Key11318693
MDR Text Key231575912
Report Number6000034-2021-00407
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 02/12/2021,01/18/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2021
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 Number126645
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/12/2021
Distributor Facility Aware Date01/18/2021
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/11/2021 Patient Sequence Number: 1
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