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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 Problems Post Operative Wound Infection (2446); Fluid Discharge (2686)
Event Type  Injury  
Event Description

Per the clinic, the patient experienced an infection and discharge at the incision site, and was treated with steroids and antibiotics (duration and date not reported). The implanted device remains. Explantation is planned but has not taken place at the time 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
MDR Report Key11032586
MDR Text Key222283121
Report Number6000034-2020-03656
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,Followup
Report Date 02/10/2021,01/18/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2020
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 Number130947
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/10/2021
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: 12/17/2020 Patient Sequence Number: 1
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