BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNBEAM

    MDR report key: 21814623 · Received April 10, 2025

    Report

    Report Number
    3007790958-2025-00017
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    March 4, 2025
    Report Date
    April 10, 2025
    Manufacturer
    EAGLE ELECTRIC CO.,LTD
    Product Code
    IRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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

    AN CLAIMS MANAGEMENT SERVICES OFFICE IS FILING A LETTER NOTICE UNDER CASE REFERENCE NUMBER (B)(4) ALLEGING THAT A HEATING PAD WAS THE CAUSE OF A BURN TO ITS CLIENT'S BODY. THERE WAS NOT A REPORT OF PROPERTY DAMAGE(S) WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816622 SUNBEAM HEATING PAD IRT EAGLE ELECTRIC CO.,LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other