BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTHEAT

    MDR report key: 4121812 · Received July 28, 2014

    Report

    Report Number
    1314800-2014-00061
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 25, 2014
    Manufacturer
    KAZ USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER CALLED TO REPORT THAT A HEATING PAD THAT SHE OWNED HAD ALLEGEDLY CAUGHT ON FIRE. SHE STATED THAT THIS HEATING PAD CAUSED RED MARKS ON HER FOREARMS, DAMAGE TO A BED SHEET, AND ALSO HAD A BURN HOLE IN THE PRODUCT ITSELF. THERE WAS NO ADVERSE EVENT REPORTED, AND MEDICAL ATTENTION WAS NOT REQUIRED. INCIDENTS OF THIS NATURE ARE MOST LIKELY CAUSED BY THE CONSUMER LAYING OR LEANING AGAINST THE PAD WHICH IS CONTRARY TO PROPER USE INSTRUCTION. THE PRODUCT HAS A CLEAR WARNING THAT STATES THE PRODUCT IS INTENDED FOR USE ON TOP OF THE BODY, AND CONSUMERS SHOULD NOT SIT AGAINST OR LAY ON TOP OF THE HEATING PAD. THE INSTRUCTIONS ALSO HAVE A WARNING TO NEVER PLACE THE PAD BETWEEN YOURSELF AND A CHAIR, SOFA, BED, OR PILLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439988 SOFTHEAT HEATING PAD IRT KAZ USA, INC. HP950 04813ART

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK