BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2418284 · Received January 3, 2012

    Report

    Report Number
    1314800-2011-00058
    Event Type
    Other
    Date Received
    January 3, 2012
    Date of Event
    December 28, 2011
    Report Date
    December 30, 2011
    Manufacturer
    KAZ INC
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING A THIRD DEGREE BURN TO HER STOMACH FROM THE HEATING PAD. SHE DID SEEK MEDICAL ATTENTION FOR HER INJURY. BURNS OF THIS NATURE ARE THE RESULT OF LAYING OR LEANING AGAINST THE HEATING PAD WHICH IS CONTRARY TO PROPER USE INSTRUCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other