BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 1053523 · Received May 28, 2008

    Report

    Report Number
    1811605-2008-00080
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 29, 2008
    Manufacturer
    BATTLE CREEK EQUIPMENT CO
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED AN INTERNAL ELECTRICAL COMPONENT BURNED. OUR INSPECTION OF THE UNIT REVEALED A BROKEN LEAD WIRE RESULTING IN A 1/4" BURN HOLE IN THE FABRIC FOUNDATION OF THE UNIT. SEVERAL INTERNAL COMPONENTS WERE BENT, ALONG WITH INDICATIONS THAT THE UNIT HAD BEEN BUNCHED REPEATEDLY AT THE BREAK, WHICH IS A CLEAR VIOLATION OF OUR USER WARNINGS AND INSTRUCTIONS. WE DETERMINED THAT THIS REPORT WAS ATTRIBUTABLE TO MISUSE 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