BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCO PROFLUORID VARNISH

    MDR report key: 15603865 · Received October 14, 2022

    Report

    Report Number
    8010908-2022-00002
    Event Type
    Injury
    Date Received
    October 14, 2022
    Date of Event
    June 16, 2022
    Report Date
    October 14, 2022
    Manufacturer
    VOCO GMBH
    Product Code
    LBH
    PMA / PMN Number
    K080814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED PRODUCT WAS NOT SENT IN AND COULD NOT BE CHECKED. VOCO PROFLUORID VARNISH CONTAINS ROSIN AND ARTIFICIAL FLAVORS. INTOLERANCE TO THESE INGREDIENTS CANNOT BE RULED OUT IN RARE CASES. THE INSTRUCTIONS FOR USE CONTAIN APPROPRIATE WARNINGS. A REACTION TO THE SODIUM FLUORIDE CONTAINED IS UNLIKELY. ACCORDING TO EXPERIENCE, THE REQUIRED AMOUNT FOR A COMPLETE SET OF TEETH IS BETWEEN 0.25 ML AND 0.40 ML. THE FLUORIDE CONTENT OF A SINGLE DOSE IS FAR BELOW THE POTENTIALLY TOXIC DOSE OF 5MG PER KG BODY WEIGHT.

    Description of Event or Problem · 0

    AFTER ADMINISTRATION OF THE VARNISH, THE PATIENT SUFFERED FROM PERSISTENT NAUSEA, WHICH LATER TURNED INTO VOMITING. THE PATIENT WAS HOSPITALIZED WITH AN INFUSION. THE SYMPTOMS HAD COMPLETELY SUBSIDED AFTER ONE DAY. THE PATIENT HAS FULLY RECOVERED WITHOUT ANY CONSEQUENTIAL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273259 VOCO PROFLUORID VARNISH PROFLUORID VARNISH LBH VOCO GMBH 2223188

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization