BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE ARTHRITIS PAD

    MDR report key: 1032278 · Received April 21, 2008

    Report

    Report Number
    1811605-2008-00061
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 1, 2008
    Report Date
    April 3, 2008
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE SWITCH EMITTED SMOKE. EXAMINATION OF THE INTERNAL COMPONENTS OF THE SWITCH REVEALED THE CIRCUIT BOARD HAD BURNED 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 155

    Patients

    Seq Age Sex Outcome Treatment
    1