BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 3820054 · Received May 13, 2014

    Report

    Report Number
    1314800-2014-00051
    Event Type
    Other
    Date Received
    May 13, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 12, 2014
    Manufacturer
    KAZ USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER CALLED AND STATED THAT HIS WIFE WAS ALLEGEDLY BURNED WHILE USING A HEATING PAD. THIS INCIDENT RESULTED IN THIRD DEGREE BURNS ON HER UPPER THIGH. THE PT STATED THAT SHE WAS TREATED BY A DOCTOR, AND MAY REQUIRE SURGERY. BURNS OF THIS NATURE ARE MOST LIKELY CAUSED BY THE CONSUMER LAYING OR LEANING AGAINST THE PAD WHICH IS CONTRARY TO PROPER US 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
    287453 SOFTHEAT HEATING PAD IRT KAZ USA, INC. HP115 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other