BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 1082661 · Received July 21, 2008

    Report

    Report Number
    1811605-2008-00102
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 20, 2008
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE SWITCH FLICKERED AND MAY HAVE SHORTED OR SPARKED. VISUAL EXAMINATION AND ELECTRICAL TESTING OF THE UNIT REVEALED NO SPARK, SHORT OR OTHER DEFECT, ALTHOUGH INTERNAL COMPONENTS WERE DAMAGED AND THE FABRIC FOUNDATION WAS BADLY DISCOLORED FROM MISUSE, FOLDING WHILE IN USE, AND EXCESSIVE LEVELS OF HEAT. WE WERE UNABLE TO DETECT ANY DEFECT IN THE PERFORMANCE OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOPHORE AUTOMATIC MOIST HEAT PACK ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT COMPANY 055

    Patients

    Seq Age Sex Outcome Treatment
    1