BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE ARTHRITIS PAD

    MDR report key: 2043034 · Received March 15, 2011

    Report

    Report Number
    1811605-2011-00027
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 1, 2010
    Report Date
    March 2, 2011
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED AN INTERNAL ELECTRICAL COMPONENT SPARKED AND BURNED THE FABRIC FOUNDATION OF THE UNIT. EXAMINATION OF THE PAD SHOWS ARCING BETWEEN THE LEADS OF ONE OF THE THERMOSTATS THAT RESULTED IN A 1/4" BURN HOLE IN THE COVER OF THE PAD. OTHER EVIDENCE (THE BUNCHED UP CONDITION OF THE PAD AND THE TAPED-DOWN SAFETY SWITCH) SUGGEST THE UNIT WAS USED IMPROPERLY. WE CONCLUDED THAT THIS REPORT WAS ATTRIBUTABLE TO MISUSE OF THE PRODUCT ON THE PART OF THE CONSUMER. THIS PARTICULAR STYLE OF THERMOSTAT WAS CHANGED SEVERAL YEARS AGO TO A DESIGN THAT PREVENTS ARCING IN ABUSE CONDITIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED AN INTERNAL ELECTRICAL COMPONENT SPARKED AND BURNED THE FABRIC FOUNDATION OF THE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1