BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK, WAS APPLIED IN ER

    MDR report key: 1341596 · Received March 10, 2009

    Report

    Report Number
    MW5010272
    Event Type
    Other
    Date Received
    March 10, 2009
    Date of Event
    June 2, 2008
    Report Date
    March 10, 2009
    Manufacturer
    UNK
    Product Code
    DRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TRANSDERMAL PATCH USED IN MRI AND CARDIAC TEST. THE LEAD PATCH. THE LEADS FOR THE CARDIAC MONITOR PRIOR TO MY MRI OR CAT IN ER WAS APPLIED. AFTER MY TESTS, THEY PULLED OFF THE LEADS AND ONE OF LEADS BURNED MY SKIN. THE NEXT DAY, IT RESULTED IN A LARGE WATERY TYPE SKIN BURN BLISTER THAT BROKE OPEN LEAKING FLUIDS WHICH BURNED MY SKIN. I HAVE A LARGE SCAR RESULTING FROM THAT MONITOR LEAD. IT BURNED MY SKIN. THE SIZE OF THE SCAR IS ABOUT LIKE A 50 CENT PIECE. DIAGNOSIS: KIDNEY STONE IN ER. ONLY THAT ONE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK, WAS APPLIED IN ER LEADS FOR CARDIAC TESTING, LEAD PATCH DRX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other