BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCO PROFLUORID VARNISH

    MDR report key: 16875153 · Received May 5, 2023

    Report

    Report Number
    8010908-2023-00004
    Event Type
    Injury
    Date Received
    May 5, 2023
    Manufacturer
    VOCO GMBH
    Product Code
    LBH
    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 COLOPHONY AND ARTIFICIAL FLAVORS. INTOLERANCES TO THESE INCREDIENTS CANNOT BE RULED OUT IN RARE CASES. THE INSTRUCTION FOR USE CONTAIN APPROPRIATE WARNINGS.

    Description of Event or Problem · 0

    ONE PATIENT COMPLAINED OF A BURNING SENSATION OF THE ORAL MUCOSA AND REDNESS EXTENDING TO THE NECK AREA ONE DAY AFTER TREATMENT WITH VOCO PROFLUORIDE VARNISH. HOSPITALIZATION WAS NOT REQUIRED. MEDICAL OR PHYSICIAN INTERVENTIONS AS A RESULT OF THE ALLERGIC REACTION AND THE PATIENT'S CURRENT CONDITION ARE NOT KNOWN TO THE TREATING DENTIST. THE INFORMATION COULD NOT BE OBTAINED UPON REQUEST. IN CASE OF RE-EXPOSURE TO THE VARNISH, MORE SERIOUS CONSEQUENCES FOR THE PATIENT CANNOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672900 VOCO PROFLUORID VARNISH PROFLUORID VARNISH LBH VOCO GMBH 2246542

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other