BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 3788322 · Received April 25, 2014

    Report

    Report Number
    1314800-2014-00042
    Event Type
    Other
    Date Received
    April 25, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 23, 2014
    Manufacturer
    KAZ USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER CALLED TO REPORT THAT SHE HAD ALLEGEDLY BEEN BURNED BY A HEATING PAD. THIS INCIDENT RESULTED IN BLISTERS ON HER RIGHT THIGH, WHICH RESULTED IN AN INFECTION. THE PATIENT IS CURRENTLY BEING TREATED BY HER PHYSICIAN AND HAS BEEN PRESCRIBED ANTIBIOTICS. BURNS OF THIS NATURE ARE MOST LIKELY CAUSED BY THE CONSUMER LAYING OR LEANING AGAINST THE PAD WHICH IS CONTRARY TO PROPER INSTRUCTIONS. 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
    250590 SOFTHEAT HEATING PAD IRT KAZ USA, INC. HP5OS-CAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other