BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC HEAT PACK

    MDR report key: 3843821 · Received May 24, 2014

    Report

    Report Number
    1811605-2014-00121
    Event Type
    Malfunction
    Date Received
    May 24, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 23, 2014
    Manufacturer
    BATTLE CREEK EQUIPMENT
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED THE SWITCH CAUGHT FIRE WHILE USING IT. UPON INVESTIGATION, WE FOUND THAT THE CORD HAD BEEN SEVERED BY AN EXTERNAL SOURCE. UPON FURTHER INVESTIGATION, WE FOUND: CORD CUT: NO BURNS, SWITCH OK, PAD BUNCHED, BENT/BROKEN LEAD, BENT/BROKEN THERMOSTAT, THERMOSTAT DISCOLORATION. BASED ON THE OVERALL CONDITION OF THE PAD, WE CONCLUDED THAT THE HEATING PAD WAS NOT USED IN ACCORDANCE WITH OUR INSTRUCTIONS.

    Description of Event or Problem · 1

    CUSTOMER STATED THE SWITCH CAUGHT FIRE WHILE HOLDING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309663 THERMOPHORE AUTOMATIC HEAT PACK ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT 055

    Patients

    Seq Age Sex Outcome Treatment
    1