BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 3690785 · Received March 17, 2014

    Report

    Report Number
    1314800-2014-00021
    Event Type
    Other
    Date Received
    March 17, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 13, 2014
    Manufacturer
    KAZ USA, INC
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER CALLED TO REPORT THAT THEY HAD BEEN BURNED BY A HEATING PAD. THE CONSUMER STATED THAT THIS INCIDENT OCCURRED WHEN HE WAS LAYING ON TOP OF THE HEATING PAD. THIS INCIDENT RESULTED IN BLISTER ON HIS SIDE, AND HE DID NOT SEEK MEDICAL ATTENTION. THE PRODUCT HAS A CLEAR WARNING THAT STATES THE PRODUCT IS INTENDED FOR USE ON TOP OF THE BODY, AND CONSUMERS SHOULD NOT SIT 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
    156819 SOFTHEAT HEATING PAD IRT KAZ USA, INC HP215 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other