BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 3815150 · Received May 6, 2014

    Report

    Report Number
    1314800-2014-00049
    Event Type
    Other
    Date Received
    May 6, 2014
    Date of Event
    March 1, 2014
    Report Date
    May 5, 2014
    Manufacturer
    KAZ USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER CALLED TO REPORT THAT SHE HAD ALLEGEDLY BEEN BURNED WHILE LAYING ON TOP OF A HEATING PAD, WHICH IS CONTRARY TO PROPER USE INSTRUCTION. THIS INCIDENT RESULTED IN THIRD DEGREE BURNS ON HER BUTTOCKS. THE PT WAS TREATED BY HER DOCTOR, AND IS DOING FINE NOW. 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
    271850 SOFTHEAT HEATING PAD IRT KAZ USA, INC. HP215

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other