BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 13366638 · Received January 27, 2022

    Report

    Report Number
    3007790958-2022-00004
    Event Type
    Injury
    Date Received
    January 27, 2022
    Report Date
    February 1, 2022
    Manufacturer
    SUNBEAM PRODUCTS, INC.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    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.

    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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327914 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC. 764-690

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other