BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEATING PAD

    MDR report key: 3224269 · Received July 11, 2013

    Report

    Report Number
    MW5030843
    Event Type
    Other
    Date Received
    July 11, 2013
    Date of Event
    April 3, 2012
    Report Date
    June 11, 2013
    Manufacturer
    SUNBEAM
    Product Code
    IRT
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT ON (B)(6) 2012, SHE USED A HEATING PAD SHE BOUGHT FROM (B)(6). SHE KEPT THE PAD ACROSS HER STOMACH AND SWITCHED IT ON TO MIDDLE, UNFORTUNATELY AFTER A FEW MINUTES, SHE FELT NO HEAT, SHE THEN TURNED THE PAD UP TO HIGH. AFTER SHE FELT THE PAD WAS TOO HOT (OVERHEAT) AND SHE REMOVED IT BY THROWING IT ON THE FLOOR AND UNPLUGGED IT. THE FOLLOWING MORNING, SHE WOKE UP TO FEEL SOMETHING FUNNY ON HER STOMACH AREA LIKE SHINGLES, REDNESS, AND ALSO FELT VERY SICK. SHE WENT TO HER DOCTOR WHO CONFIRMED THAT SHE WAS A SECOND DEGREE THERMAL BURN FROM THE HEATING PAD. SHE WAS GIVEN A PRESCRIPTION FOR TOPOMAX. SHE ALSO STATED SHE WAS MADE TO SIGN A WAIVER BY (B)(6) WITHOUT KNOWING WHAT SHE SIGNED. SHE COMPLAINED SHE NOW HAS A PERMANENT SCAR IN HER TORSO AREA BECAUSE OF THIS BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320609 HEATING PAD HEATING PAD IRT SUNBEAM E13107

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR