BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 11820170 · Received May 13, 2021

    Report

    Report Number
    3007790958-2021-00050
    Event Type
    Injury
    Date Received
    May 13, 2021
    Report Date
    June 16, 2021
    Manufacturer
    SUNBEAM PRODUCTS, INC.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONSUMER ADMITS TO LAYING ON THE HEATING PAD WHICH IS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. 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, "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION. HEATING PAD IS BUNCHED/CRUSHED WHICH SHOWS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. THIS INCIDENT IS THE DIRECT RESULT OF CONSUMER MISUSE/ABUSE OF THE PRODUCT.

    Description of Event or Problem · 0

    CONSUMER ALLEGES LAYING AGAINST HEATING PAD WHILE IN BED THEN FELL ASLEEP AND AWOKE TO A BURN ON HER UPPER RIGHT BACK. THERE WAS NOT A REPORT OF PROPERTY DAMAGE WITH THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    CONSUMER ADMITS TO LAYING ON THE HEATING PAD WHICH IS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. 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, 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 LAYING AGAINST HEATING PAD WHILE IN BED THEN FELL ASLEEP AND AWOKE TO A BURN ON HER UPPER RIGHT BACK. THERE WAS NOT A REPORT OF PROPERTY DAMAGE WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716742 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC. 764

    Patients

    Seq Age Sex Outcome Treatment
    1 Other