BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 11633963 · Received April 8, 2021

    Report

    Report Number
    3007790958-2021-00039
    Event Type
    Injury
    Date Received
    April 8, 2021
    Report Date
    April 8, 2021
    Manufacturer
    SUNBEAM PRODUCTS, INC.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS AN INSTRUCTION THAT STATES, "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION. THERE IS AN INSTRUCTION THAT STATES, "THIS PAD IS NOT TO BE USED ON OR BY AN INVALID, A SLEEPING OR UNCONSCIOUS PERSON, A PERSON WITH DIABETES, OR A PERSON WITH POOR BLOOD CIRCULATION OR INSENSITIVITY TO HEAT, OR A PERSON INCAPACITATED BY MEDICATION" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION.

    Description of Event or Problem · 1

    CONSUMER ALLEGES USING HER HEATING PAD AND RECEIVED A BURN ON HER RIGHT HIP. THERE WAS NOT A REPORT OF PROPERTY DAMAGE WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536123 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC. 720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other