BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDICAL ADVANCES

    MDR report key: 642803 · Received August 30, 2005

    Report

    Report Number
    2183683-2005-00001
    Event Type
    Other
    Date Received
    August 30, 2005
    Date of Event
    June 21, 2005
    Report Date
    June 22, 2005
    Manufacturer
    MEDICAL ADVANCES INC
    Product Code
    MOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL ADVANCES LOWER EXTREMITY COIL MOS MEDICAL ADVANCES INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR