BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL ADVANCES

    MDR report key: 5429943 · Received June 24, 2005

    Report

    Report Number
    5429943
    Event Type
    Malfunction
    Date Received
    June 24, 2005
    Date of Event
    June 21, 2005
    Report Date
    June 22, 2005
    Manufacturer
    MEDICAL ADVANCES, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITNESSED A PUFF OF SMOKE AND A RED AREA OF COIL THAT APPEARED TO BE BURNING. DURING A SCAN THE AREA WAS ON THE CHIMNEY APERTURE. SCANNING WAS IMMEDIATELY STOPPED. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL ADVANCES LOWER EXTREMITY COIL HCG MEDICAL ADVANCES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR