BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 24097131 · Received January 16, 2026

    Report

    Report Number
    3007007357-2026-00001
    Event Type
    Injury
    Date Received
    January 16, 2026
    Date of Event
    December 16, 2025
    Report Date
    January 16, 2026
    Manufacturer
    MONITEX INDUSTRIAL CO. LTD.
    Product Code
    EBZ
    UDI-DI
    00304040186008
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE CURING LIGHT GETS TOO HOT AND BURNED A PATIENT DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154132 HENRY SCHEIN CURING LIGHT EBZ MONITEX INDUSTRIAL CO. LTD. MAXIMA ADVANCED 3000 LED 00304040186008

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other