BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 12481121 · Received September 16, 2021

    Report

    Report Number
    3010805625-2021-00068
    Event Type
    Injury
    Date Received
    September 16, 2021
    Date of Event
    September 2, 2021
    Report Date
    September 27, 2021
    Manufacturer
    SUNBEAM PRODUCTS, INC.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 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 THE HEATING PAD WHILE IN BED AND RECEIVED BURNS ON HER UPPER RIGHT BACK AREA. 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. 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 THE HEATING PAD WHILE IN BED AND RECEIVED BURNS ON HER UPPER RIGHT BACK AREA. THERE WAS NOT A REPORT OF PROPERTY DAMAGE WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381226 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC. 731

    Patients

    Seq Age Sex Outcome Treatment
    1 Other