BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 3854838 · Received May 22, 2014

    Report

    Report Number
    3007790958-2014-00092
    Event Type
    Injury
    Date Received
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    SUNBEAM PRODUCTS, INC.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER ADMITS TO BURNS ON HER BUTTOCKS WHICH INDICATES SHE WAS SITTING / LEANING ON THE HEATING PAD WHICH IS ABUSE OF THE PRODUCT AND VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. CONSUMER ADMITS TO FALLING ASLEEP WHILE USING THE PAD WHICH IS ABUSE OF THE PRODUCT AND VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. THERE IS AN INSTRUCTION THAT STATES, "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY" AND CONSUMER FAILED TO PERFORMED THAT INSTRUCTION.

    Description of Event or Problem · 1

    CONSUMER CLAIMS SHE WAS USING A HEATING PAD DURING THE NIGHT FOR HER LOWER BACK AND FELL ASLEEP. AFTER 30 MINUTES SHE NOTICED SHE HAD TWO BLISTERS ON HER BUTTOCKS. SHE IS ALLEGING THAT SHE SUFFERED 2ND DEGREE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306816 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other