BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 1082561 · Received July 21, 2008

    Report

    Report Number
    1811605-2008-00111
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 7, 2008
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE UNIT BURNED. VISUAL INSPECTION OF THE UNIT REVEALED THAT SEVERAL INTERNAL COMPONENTS WERE BENT AND A SEGMENT OF THE LEAD WIRE HAD BROKEN IN ONE AREA, ALLOWING A SPARK TO CONTACT THE FABRIC FOUNDATION AND CAUSING A BURN. WE DETERMINED THAT THIS REPORT WAS ATTRIBUTABLE TO MISUSE OF THE UNIT ON THE PART OF THE CONSUMER.

    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 COMPANY 055

    Patients

    Seq Age Sex Outcome Treatment
    1