BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 1162254 · Received September 4, 2008

    Report

    Report Number
    1811605-2008-00128
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 11, 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 THE UNIT BURNED. VISUAL INSPECTION OF THE UNIT REVEALED THAT INTERNAL COMPONENTS WERE BENT AND A SEGMENT OF THE LEAD WIRE HAD BROKEN, ALLOWING A SPARK TO CONTACT THE FABRIC FOUNDATION AND CAUSING A 1/2" BURN HOLE. WE WERE UNABLE TO DETERMINE THE CAUSE OF THIS REPORT.

    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