BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 4620575 · Received March 16, 2015

    Report

    Report Number
    1314800-2015-00010
    Event Type
    Other
    Date Received
    March 16, 2015
    Date of Event
    January 3, 2015
    Report Date
    March 12, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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 THIRD DEGREE BURNS ON HER HIP, AND IT IS UNK IF SHE REQUIRED MEDICAL TREATMENT FOR THIS INJURY. THE PT 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
    178197 SOFTHEAT HEATING PAD IRT KAZ USA, INC. HP-980 23413

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other