BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 2220158 · Received August 15, 2011

    Report

    Report Number
    1811605-2011-00096
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BATTLE CREEK EQUIPMENT CO.
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE UNIT STOPPED WORKING. EXAMINATION OF THE UNIT REVEALED A BREAK IN THE CORD AT THE ENTRANCE TO THE STRAIN RELIEF AREA NEAR THE SWITCH. THE BREAK PREVENTS THE WIRES IN THE CORD FROM MAKING CONTINUOUS CONTACT AND COULD POSSIBLY EXPOSE BARE WIRES WHEN THE CORD IS BENT. THE FAILURE MAY BE A RESULT OF MISUSE OR FAILURE TO FOLLOW INSTRUCTIONS ON THE PART OF THE CONSUMER BY SUBJECTING THE CORD TO EXCESSIVE BENDING. THE CONDITION OF THE PAD SUGGESTS IT WAS USED EXCESSIVELY AND INCORRECTLY. ALTHOUGH USERS ARE INSTRUCTED NOT TO BEND THE CORD NEAR THE SWITCH, WE ARE TAKING APPROPRIATE ACTION TO MAKE THE DESIGN MORE ROBUST BY INITIATING A CAPA PROJECT ((B)(4)) TO PREVENT THIS FAILURE FROM RECURRING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE UNIT STOPPED WORKING.

    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