BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 2120464 · Received May 27, 2011

    Report

    Report Number
    1314800-2011-00022
    Event Type
    Other
    Date Received
    May 27, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 19, 2011
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING BURNS TO HER BACK AND HIP FROM USING THE HEATING PAD. SHE STATED SHE WAS LEANING AGAINST THE PAD ON THE BACK OF A CHAIR, THIS TYPE OF OPERATION IS CONTRARY TO PROPER USE INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTHEAT HEATING PAD IRT KAZ, INC. HP950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other