BEUDAMED
    FDA Adverse Event Other Summary report: N

    KAZ SMARTHEAT

    MDR report key: 2061050 · Received April 4, 2011

    Report

    Report Number
    1314800-2010-00059
    Event Type
    Other
    Date Received
    April 4, 2011
    Date of Event
    January 25, 2008
    Report Date
    April 1, 2011
    Manufacturer
    KAZ INC
    Product Code
    IRT
    PMA / PMN Number
    NA
    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 BURN TO HER LEFT HIP FROM THE HEATING PAD. SHE DID SEEK MEDICAL TREATMENT FOR HER BURNS. BURNS OF THIS NATURE ARE CAUSED BY THE CONSUMER 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 KAZ SMARTHEAT HEATING PAD IRT KAZ INC HP215 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other