BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE ARTHRITIS PAD

    MDR report key: 1250712 · Received December 1, 2008

    Report

    Report Number
    1811605-2008-00145
    Event Type
    Malfunction
    Date Received
    December 1, 2008
    Date of Event
    November 1, 2008
    Report Date
    November 13, 2008
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE SWITCH FAILED TO FUNCTION AND BEGAN TO EMIT A BURNING ODOR. EXAMINATION OF THE INTERNAL COMPONENTS OF THE SWITCH REVEALED A RESISTOR ON THE CIRCUIT BOARD HAD SHORTED OUT, BUT WE WERE UNABLE TO DETERMINE THE CAUSE. WE ATTRIBUTED THIS REPORT TO AN UNUSUAL PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOPHORE ARTHRITIS PAD ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT COMPANY 156

    Patients

    Seq Age Sex Outcome Treatment
    1