BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 1802702 · Received August 6, 2010

    Report

    Report Number
    1314800-2008-00017
    Event Type
    Other
    Date Received
    August 6, 2010
    Date of Event
    February 27, 2008
    Report Date
    August 3, 2010
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTED RECEIVING 2ND DEGREE BURNS TO HER BACK AND ARM WHILE USING THE HEATING PAD. SHE WAS LAYING ON THE PAD AT THE TIME OF THE INCIDENT WHICH IS CONTRARY TO PROPER USE INSTRUCTION. THE CONSUMER DID SEEK MEDICAL ATTENTION FOR HER BURNS AND IS CURRENTLY HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ, INC. HP710 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other