BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCO PROFLUORID VARNISH MELON

    MDR report key: 25110143 · Received May 7, 2026

    Report

    Report Number
    8010908-2026-00001
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    March 24, 2026
    Report Date
    May 7, 2026
    Manufacturer
    VOCO GMBH
    Product Code
    LBH
    UDI-DI
    E22100160000000008E
    PMA / PMN Number
    K080814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VOCO PROFLUORID VARNISH CONTAINS ROSIN AND ARTIFICIAL FLAVOURINGS. INTOLERANCE TO THESE INGREDIENTS CANNOT BE RULED OUT IN RARE CASES. INSTRUCTION FOR USE CONTAINS APPROPRIATE WARNINGS.

    Description of Event or Problem · 0

    ONE PATIENT DEVELOPED A RASH THE EVENING AFTER BEING TREATED WITH VOCO PROFLUORID VARNISH MELON, MAINLY ON THE MOUTH AND HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208707 VOCO PROFLUORID VARNISH MELON VOCO PROFLUORID VARNISH MELON LBH VOCO GMBH 2604769 E22100160000000008E

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Other