BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 3003517 · Received February 11, 2013

    Report

    Report Number
    1811605-2013-00012
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE FABRIC FOUNDATION OF THE UNIT WAS BURNED BY AN INTERNAL COMPONENT. OUR EXAMINATION REVEALED THAT ONE OF THE TERMINALS HAD BEEN BROKEN NEAR A THERMOSTAT, RESULTING IN A SPARK WHICH HAD CAUSED A 1/4" BURN HOLE IN ONE SIDE (BOTH SIDES) OF THE FABRIC FOUNDATION. THIS TYPE OF INCIDENT IS NORMALLY CAUSED BY MISUSE ON THE PART OF THE CONSUMER, BUT THERE WERE NO ADDITIONAL SIGNS OF BROKEN COMPONENTS OR MISUSE. WE WERE UNABLE TO DETERMINE THE CAUSE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD A SMALL BURN HOLE AND WOULD NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60385 THERMOPHORE AUTOMATIC MOIST HEAT PACK ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT COMPANY 156

    Patients

    Seq Age Sex Outcome Treatment
    1