BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 3760979 · Received April 11, 2014

    Report

    Report Number
    3007790958-2014-00071
    Event Type
    Injury
    Date Received
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    SUNBEAM PRODUCTS INC
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER ADMITS TO SLEEPING WITH THE HEATING PAD WHICH IS A DIRECT VIOLATION OF THE INSTRUMENTS AND WARNINGS PROVIDED. A PREPAID LABEL HAS BEEN SENT TO THE CONSUMER FOR A RETURN OF THE PRODUCT. CONSUMER HAS NOT RETURNED THE PRODUCT.

    Description of Event or Problem · 1

    CONSUMER CLAIMS HE FELL ASLEEP WHILE LAYING ON A HEATING PAD AND AWOKE THE NEXT MORNING WITH BURN MARKS AND WATER BLISTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221208 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS INC 811-715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other