BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 1162243 · Received September 4, 2008

    Report

    Report Number
    1811605-2008-00127
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    August 1, 2008
    Report Date
    July 19, 2008
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    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 ELECTRICAL CORD EMITTED SPARKS. VISUAL INSPECTION OF THE UNIT REVEALED A BREAK IN THE LINE CORD NEAR THE STRAIN RELIEF.

    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