BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUNLAP

    MDR report key: 1122485 · Received August 14, 2008

    Report

    Report Number
    1314800-2008-00004
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    February 24, 2008
    Report Date
    August 14, 2008
    Manufacturer
    KAZ, INC.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTED USING PAD SET ON LOW POSITION WHILE IN BED. CONSUMER MISTAKENLY TURNED PAD TO HIGH POSITION (MEANT TO TURN PAD TO OFF POSITION), THEN FELL ASLEEP. CONSUMER AWOKE SEVERAL HOURS LATER TO FIND BURN ON BUTTOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUNLAP HEATING PAD IRT KAZ, INC. HP110 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other