BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 1203252 · Received October 9, 2008

    Report

    Report Number
    1811605-2008-00133
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 4, 2008
    Manufacturer
    BATTLE CREEK EQUIPMENT CO.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED AN INTERNAL ELECTRICAL COMPONENT BURNED. OUR INSPECTION OF THE UNIT REVEALED A BROKEN TERMINAL NEAR THE THERMOSTAT, RESULTING IN A 1/4" BURN HOLE IN THE FABRIC FOUNDATION OF THE UNIT. WE ALSO NOTED SEVERAL OTHER INTERNAL COMPONENTS OF THE UNIT HAD BEEN BENT AND BROKEN BY MISUSE. THE CUSTOMER REPORTED USE OF THE PRODUCT UNDER THE PT, IN CONJUNCTION WITH A ROLLING-COMPRESSION BED, WHICH IS A CLEAR CONTRADICTION OF OUR INSTRUCTIONS AND WARNINGS. WE DETERMINED THAT THIS REPORT WAS ATTRIBUTABLE TO MISUSE OF THE UNIT ON THE PART OF THE USER.

    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 CO. 055

    Patients

    Seq Age Sex Outcome Treatment
    1