BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRADENT ENAMELON FLUORIDE VARNISH

    MDR report key: 19839272 · Received July 25, 2024

    Report

    Report Number
    MW5157630
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    July 9, 2024
    Report Date
    July 23, 2024
    Manufacturer
    ULTRADENT PRODUCTS INC. / ORATECH LLC
    Product Code
    LBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT'S TEETH #E AND #F WERE STAINED FOLLOWING APPLICATION OF FLUORIDE VARNISH (ULTRADENT ENAMELON). VARNISH WAS ONLY APPLIED TO TEETH #E, F, AND THESE WERE THE ONLY TEETH THAT WERE STAINED BROWNISH COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016206 ULTRADENT ENAMELON FLUORIDE VARNISH VARNISH, CAVITY LBH ULTRADENT PRODUCTS INC. / ORATECH LLC 6026

    Patients

    Seq Age Sex Outcome Treatment
    1 35 MO Female