BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 11671593 · Received April 15, 2021

    Report

    Report Number
    3007790958-2021-00044
    Event Type
    Injury
    Date Received
    April 15, 2021
    Report Date
    April 15, 2021
    Manufacturer
    SUNBEAM PRODUCTS, INC.
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Description of Event or Problem · 1

    A CLAIM'S MANAGEMENT OFFICE IS FILLING A LETTER NOTICE ALLEGING THAT A HEATING PAD WAS THE CAUSE OF A BURN TO IT'S CLIENT'S BODY. THERE WAS NOT A REPORT OF PROPERTY DAMAGE WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572194 SUNBEAM HEATING PAD IRT SUNBEAM PRODUCTS, INC. 2013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other