BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 3853749 · Received May 30, 2014

    Report

    Report Number
    1314800-2014-00054
    Event Type
    Other
    Date Received
    May 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 28, 2014
    Manufacturer
    KAZ, USA INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE WAS ALLEGEDLY BURNED WHILE USING A HEATING PAD. SHE STATED THAT SHE RECEIVED THIRD DEGREE BURNS ON HER RIBS FROM THIS INCIDENT, AND IS CURRENTLY BEING TREATED AT A BURN CLINIC. BURNS 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 US 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
    319920 SOFTHEAT HEATING PAD IRT KAZ, USA INC. HP218 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other