BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 4003497 · Received July 28, 2014

    Report

    Report Number
    1314800-2014-00065
    Event Type
    Other
    Date Received
    July 28, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 25, 2014
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER CALLED AND STATED THAT SHE WAS ALLEGEDLY BURNED WHILE USING A HEATING PAD. THIS INCIDENT RESULTED IN BLISTERS ON HER BACK, WHICH THE CONSUMER TREATED AT HOME WITH BURN CREAM. THE PATIENT ALSO STATED THAT THIS INCIDENT OCCURRED WHILE SHE WAS LAYING ON THE HEATING 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
    440129 SOFTHEAT HEATING PAD IRT KAZ, INC. HP950 07012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other