BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCO PROFLUORID VARNISH

    MDR report key: 8577606 · Received May 3, 2019

    Report

    Report Number
    8010908-2019-00004
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 3, 2019
    Manufacturer
    VOCO GMBH
    Product Code
    LBH
    PMA / PMN Number
    K080814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO OUR RECOMMENDATIONS IN THE INSTRUCTIONS FOR USE, A DOSAGE OF 0.25ML VPV IS UNPROBLEMATIC FOR A COMPLETE SET OF TEETH IN CHILDREN. THE FLUORIDE CONTENT OF A SINGLE DOSE IS WELL BELOW THE PROBABLY TOXIC DOSE OF 5MG PER KG BODY WEIGHT. ACCORDING TO THE DENTIST, ABOUT HALF OF A 0.4 ML SD WAS USED FOR THE TREATMENT. IN OUR EVALUATION, FLUORIDE POISONING CAN BE RULED OUT AT THIS DOSE.

    Description of Event or Problem · 1

    A DENTIST RECEIVED A CALL FROM A PARENT ON MONDAY STATING THAT THEIR CHILD HAD FLUORIDE POISONING AFTER HAVING FLUORIDE VARNISH APPLIED TO THEIR TEETH. THE CHILD HAD BEEN SEEN FOR A PROPHYLAXIS APPOINTMENT ON FRIDAY. THE CHILD HAD NAUSEA, SEVERE VOMITING AND FOOT NUMBNESS THAT STARTED FRIDAY AND LASTED OVER THE WEEKEND. THE CHILD WAS SEEN BY THE LOCAL EMERGENCY DEPARTMENT AND BOTH THE EMERGENCY DEPARTMENT AND POISON CONTROL ADVISED THE PARENT THAT THE CHILD'S VOMITING WAS DUE TO ACUTE FLUORIDE POISONING FROM FLUORIDE VARNISH APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371409 VOCO PROFLUORID VARNISH VOCO PROFLUORID VARNISH LBH VOCO GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other