BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAZ INC

    MDR report key: 47809 · Received November 1, 1996

    Report

    Report Number
    1314800-1996-90001
    Event Type
    Malfunction
    Date Received
    November 1, 1996
    Date of Event
    September 23, 1996
    Report Date
    October 18, 1996
    Manufacturer
    KAZ INC
    Product Code
    IRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER CALLED ON 9/23/96 ADVISING THAT SHE WAS SLEEPING WITH AUTO SHIFT OFF PAD ON TOP OF HER. EVEN THOUGH PAD STATES SHOULD NOT USE PRODUCT ON A SLEEPING PERSON. WHEN CONSUMER AWOKE, THE ARM HAD A BURN 2 1/2 INCHES LONG BY 1 IN WIDE. THEY IMMEDIATELY WENT TO THE DR. THEY CONFIRMED SHE HAD A THIRD DEGREE BURN ON HER ARM. CONSUMER GAVE THE HEAT PAD BACK TO DRUG STORE FOR THEM TO RETURN. THIS PRODUCT CANNOT BE LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAZ INC HEAT PAD IRT KAZ INC HP950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention