BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOPHORE AUTOMATIC HEAT PACK

    MDR report key: 3770280 · Received March 7, 2014

    Report

    Report Number
    1811605-2014-00055
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 6, 2014
    Manufacturer
    HEMI
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED THAT THE SWITCH 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. THE PAD WAS BUNCHED UP AND DIRTY. THE LEADS WERE BENT AND BROKEN. THERMOSTATS WERE DISCOLORED.

    Description of Event or Problem · 1

    CONSUMER CALLED REPORTING THAT THE PAD SPARKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139565 THERMOPHORE AUTOMATIC HEAT PACK ELECTRIC MOIST HEAT PACK IRT HEMI 055

    Patients

    Seq Age Sex Outcome Treatment
    1