BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 3131461 · Received February 25, 2013

    Report

    Report Number
    1811605-2013-00025
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT 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 BURN WHICH HAD COMPROMISED OUR DOUBLE-INSULATED DESIGN, CAUSING A 1/4" DIAMETER HOLE IN THE FABRIC FOUNDATION. WE ALSO FOUND SEVERAL OTHER INTERNAL COMPONENTS THAT WERE DAMAGED, INDICATING THAT THE CUSTOMER MISUSED THE PAD BY APPLYING AN EXCESSIVE, LOCALIZED FORCE ON OR NEAR THE THERMOSTAT TERMINAL. WE CONCLUDED THAT THIS REPORT WAS ATTRIBUTABLE TO MISUSE BY THE USER, AND FAILURE TO FOLLOW INSTRUCTIONS AS TO THE CARE AND HANDLING OF THE UNIT. ALTHOUGH WARNING LABELS AND INSTRUCTION BOOKLETS WARN AGAINST SITTING OR LAYING ON THE PRODUCT, WE HAVE A CORRECTIVE ACTION PROJECT (B)(4) UNDERWAY TO MAKE THE DESIGN MORE ROBUST.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE PAD HAD A 1/4" DIAMETER BURN HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81144 THERMOPHORE AUTOMATIC MOIST HEAT PACK ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT COMPANY 055

    Patients

    Seq Age Sex Outcome Treatment
    1