BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 2022477 · Received February 15, 2011

    Report

    Report Number
    1811605-2011-00006
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 21, 2011
    Manufacturer
    BATTLE CREEK EQUIPMENT CO.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED, THE ELECTRICAL CORD EMITTED A SPARK. EXAM OF THE CORD REVEALED A BREAK AT THE ENTRANCE TO THE STRAIN RELIEF AREA NEAR THE SWITCH. ALTHOUGH THIS IS NOT A STATISTICALLY SIGNIFICANT COMPLAINT AND MAY BE DUE TO MISUSE OR FAILURE TO FOLLOW INSTRUCTIONS ON THE PART OF THE CONSUMER, WE HAVE INITIATED CONSULTATION WITH OUR VENDOR REGARDING THIS ISSUE. WE WILL MONITOR THIS ISSUE IN A CONTINUING EFFORT TO REDUCE SIMILAR COMPLAINTS IN THE FUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE ELECTRICAL CORD EMITTED A SPARK.

    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