BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSENTIALS 2

    MDR report key: 16908768 · Received May 10, 2023

    Report

    Report Number
    3007007357-2023-00003
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    March 20, 2023
    Report Date
    May 10, 2023
    Manufacturer
    MONITEX INDUSTRIAL CO. LTD.
    Product Code
    EBZ
    UDI-DI
    00304040125656
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CUSTOMER STATED THAT PATIENT SAID THAT THE PRODUCT WAS HOT ON THE GUMS AND TEETH. THE TIP OF THE PRODUCT WAS GIVING OFF HEAT AND WILL GET HOT WITHIN 5 SECONDS OF PRESSING THE BUTTON TO START THE CURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351560 ESSENTIALS 2 CURING LIGHT EBZ MONITEX INDUSTRIAL CO. LTD. ESSENTIALS 2 LED CURING LIGHT 00304040125656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other