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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 Pain (1994)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on october 26, 2020.

 
Event Description

Per the clinic, the patient experienced pain at the magnet site. The patient underwent revision surgery (specific date not reported), in order to convert the patient to a percutaneous baha implant system. During the procedure, the internal magnet was removed, and an abutment 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
Manufacturer Contact
weiting zhen
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key10732107
MDR Text Key212969380
Report Number6000034-2020-02837
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,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 10/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2020
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
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 10/25/2020 Patient Sequence Number: 1
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