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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 Appropriate Term/Code Not Available (3191)
Patient Problems Hearing Impairment (1881); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on october 2, 2020.

 
Event Description

Per the clinic, the patient experienced deterioration in hearing. The patient underwent revision surgery under a local anaesthetic on an unknown date, 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 (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
43533
SW 43533
Manufacturer Contact
roberta loveday
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key10618309
MDR Text Key209542234
Report Number6000034-2020-02672
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeIS
PMA/PMN NumberK131240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 09/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2020
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number93550
Device Catalogue Number93550
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2020
Was Device Evaluated By Manufacturer? No
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: 10/01/2020 Patient Sequence Number: 1
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