BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2974818 · Received February 13, 2013

    Report

    Report Number
    1314800-2013-00009
    Event Type
    Other
    Date Received
    February 13, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 11, 2013
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING BURNS FROM USE OF THE HEATING PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64094 SOFTHEAT HEATING PAD IRT KAZ, INC. HP115 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other