BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2987941 · Received February 26, 2013

    Report

    Report Number
    1314800-2013-00011
    Event Type
    Other
    Date Received
    February 26, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 25, 2013
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING SEVERE BURNS ON HIS BACK FROM USING THE HEATING PAD. HE STATED HE WAS LAYING ON THE PAD AT THE TIME OF THE INCIDENT AND FELL ASLEEP. THE DIRECTIONS FOR PROPER USE STATE NOT TO LAY OR LEAN AGAINST THE HEATING PAD, OR TO USE WHILE SLEEPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81779 SOFTHEAT HEATING PAD IRT KAZ, INC. HP215 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other