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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 Abscess (1690); Unspecified Infection (1930)
Event Date 11/23/2020
Event Type  Injury  
Manufacturer Narrative

This report is submitted on december 8, 2020.

 
Event Description

Per the clinic, the patient experienced an abscess resulting in an explant of the magnet on (b)(6) 2020. It is unknown if there are plans to re-implant the patient with another device.

 
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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 Key10963304
MDR Text Key220105230
Report Number6000034-2020-03406
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 12/08/2020,11/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2020
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
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/08/2020
Distributor Facility Aware Date11/18/2020
Event Location No Information
Date Report TO Manufacturer11/18/2020
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: 12/07/2020 Patient Sequence Number: 1
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