BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2974807 · Received February 13, 2013

    Report

    Report Number
    1314800-2013-00007
    Event Type
    Other
    Date Received
    February 13, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 13, 2013
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING A SECOND DEGREE BURN ON HER SHOULDER FROM USE OF THE HEATING PAD. THE CONSUMER STATED SHE WAS LEANING AGAINST THE HEATING PAD AT THE TIME OF THE INJURY, THIS IS CONTRARY TO PROPER USE INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64410 SOFTHEAT HEATING PAD IRT KAZ, INC. HP980 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other