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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 Swelling (2091)
Event Date 06/16/2020
Event Type  Injury  
Event Description

Per the surgeon, the patient experienced swelling complications at the implant site. The patient was placed under general anaesthesia on (b)(6) 2020, in order to explant the device. There are no plans to reimplant the patient with a new device as of the date of this report.

 
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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 Key10293688
MDR Text Key199443281
Report Number6000034-2020-01818
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 06/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/19/2020
Is This An Adverse Event Report? Yes
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 Received06/26/2020
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: 07/19/2020 Patient Sequence Number: 1
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