BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATING PAD

    MDR report key: 1893134 · Received November 5, 2010

    Report

    Report Number
    MW5018053
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    CONMED
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE BECAME REALLY HOT WHILE IN USE. BREAKER ON POWER STRIP WAS TRIPPED OFF BY DEVICE. PATIENT RECEIVED A FIRST DEGREE BURN ON HIS SIDE FROM PAD. PATIENT WAS PARTIALLY LYING ON PAD. PAD HAS A VISIBLE BURN HOLE THAT GOES ALL THE WAY THROUGH. BURN HOLE IN COVER OF PAD AS WELL AS COMFORTER AND SHEETS. MATTRESS AND MATTRESS PAD WERE ALSO BURNED BY DEVICE. NO FIRE, BUT CHARRING IS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEATING PAD IRT CONMED HP15B

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other