BEUDAMED
    FDA Adverse Event Other Summary report: N

    KAZ

    MDR report key: 2033310 · Received March 17, 2011

    Report

    Report Number
    1314800-2011-00013
    Event Type
    Other
    Date Received
    March 17, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 15, 2011
    Manufacturer
    KAZ INC.
    Product Code
    IRT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE HEATING PAD CAUSED A SEVERE BURN TO HER LEG. SHE WAS SLEEPING WITH THE PAD AT THE TIME OF THE INCIDENT AND THE VINYL PAD SLIPPED OUT FROM UNDER THE COVER. USING THE PAD IN THE MANNER IS CONTRARY TO PROPER USE INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAZ HEATING PAD IRT KAZ INC. HP218 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other