BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 3760977 · Received April 11, 2014

    Report

    Report Number
    3007790958-2014-00070
    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 Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER CLAIMS SHE WAS HAVING TROUBLE SLEEPING SO SHE TOOK SOME NYQUIL AND FELL ASLEEP WHILE USING A HEATING PAD. SHE AWOKE TO FIND BURNS TO HER TIP AND TORSO. SHE SOUGHT MEDICAL TREATMENT AND CLAIMS SHE WAS DIAGNOSED WITH 1ST AND 2ND DEGREE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220655 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC. 536

    Patients

    Seq Age Sex Outcome Treatment
    1 Other