BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUNLAP

    MDR report key: 1790671 · Received August 3, 2010

    Report

    Report Number
    1314800-2008-00014
    Event Type
    Other
    Date Received
    August 3, 2010
    Date of Event
    September 12, 2008
    Report Date
    July 29, 2010
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTED RECEIVING BURNS AND BLISTERS WHILE USING THE HEATING PAD. THE BURNS WERE LOCATED ON HER LOWER BACK AND BUTTOCKS. THE LOCATION OF THE INJURIES SUGGESTS THE CONSUMER WAS SITTING OR LAYING ON THE PAD WHILE IN USE WHICH IS CONTRARY TO PROPER USE INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUNLAP HEATING PAD IRT KAZ, INC. R312WM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other