BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFTHEAT

    MDR report key: 1872384 · Received October 12, 2010

    Report

    Report Number
    1314800-2010-00038
    Event Type
    Other
    Date Received
    October 12, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 7, 2010
    Manufacturer
    KAZ INC
    Product Code
    IRT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED RECEIVING BURNS TO HER SIDE FROM THE HEATING PAD. THERE WERE BLISTERS PRESENT FROM THE BURN, THERE WAS NO MEDICAL INTERVENTION MENTIONED. SHE WAS SLEEPING WITH THE UNIT 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 HP115 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other