BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTHEAT

    MDR report key: 3236786 · Received July 15, 2013

    Report

    Report Number
    1314800-2013-00036
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 11, 2013
    Manufacturer
    KAZ USA, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING BURNS ON HER BACK FROM THE HEATING PAD. SHE STATED SHE WAS LAYING ON THE HEATING PAD AT THE TIME OF THE INCIDENT. THE INSTRUCTIONS FOR PROPER USE STATE NOT TO LAY OR LEAN AGAINST THE HEATING PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325414 SOFTHEAT HEATING PAD IRT KAZ USA, INC. HP218 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other