BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC HEAT PACK

    MDR report key: 3883848 · Received June 13, 2014

    Report

    Report Number
    1811605-2014-00135
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BATTLE CREEK EQUIPMENT
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED THAT SHE SAW SMOKE AND THEN A BURN MARK. UPON FURTHER INVESTIGATION, WE FOUND THAT THE CORD HAD BEEN SEVERED BY AN EXTERNAL SOURCE. OUR INVESTIGATION SHOWS THE SPARKING OCCURRED AS THE CORD WAS REMOVED. UPON FURTHER INVESTIGATION WE FOUND: POLY COVER DIRTY OR STAINED, FDA: CORD CUT/BURNED OTHER LOCATION, SWITCH OK, PAD BUNCHED, BENT/BROKEN LEAD, BENT/BROKEN THERMOSTAT, THERMOSTAT DISCOLORATION, PAD DIRTY OR STAINED. 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 THAT SWITCH CAUGHT ON FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351235 THERMOPHORE AUTOMATIC HEAT PACK ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT 055

    Patients

    Seq Age Sex Outcome Treatment
    1