BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 12015697 · Received June 17, 2021

    Report

    Report Number
    3007790958-2021-00057
    Event Type
    Injury
    Date Received
    June 17, 2021
    Report Date
    June 17, 2021
    Manufacturer
    SUNBEAM PRODUCTS, INC.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER ADMITS TO SLEEPING WHILE USING THE HEATING PAD WHICH IS A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. THERE IS AN INSTRUCTION THAT STATES, "DO NOT SIT ON, AGAINST, OR CRUSH PAD-AVOID SHARP FOLDS. PLACE PAD ON TOP OF AND NOT UNDER THE PART OF BODY NEEDING HEAT" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION. 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.

    Description of Event or Problem · 1

    CONSUMER ALLEGES SLEEPING WITH HER HEATING PAD THEN AWOKE TO A BURN ON HER RIGHT LEG NEAR THE KNEE. THERE WAS NOT A REPORT OF PROPERTY DAMAGE WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915689 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other