BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC MOIST HEAT PACK

    MDR report key: 3170628 · Received April 18, 2013

    Report

    Report Number
    1811605-2013-00043
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 20, 2013
    Manufacturer
    BATTLE CREEK EQUIPMENT COMPANY
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED THAT PAD SPARKED. 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 SEVERED. 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

    THE USER REPORTED THAT SHE COULD SMELL SOMETHING BURNING WHEN SHE TURNED IT ON BUT DIDN'T KNOW THAT. UPON FURTHER INVESTIGATION, WE FOUND THAT THE CORD HAD BEEN SEVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168749 THERMOPHORE AUTOMATIC MOIST HEAT PACK ELECTRIC MOIST HEAT PACK IRT BATTLE CREEK EQUIPMENT COMPANY 056

    Patients

    Seq Age Sex Outcome Treatment
    1