BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCO PROFLUORID VARNISH

    MDR report key: 8099832 · Received November 23, 2018

    Report

    Report Number
    8010908-2018-00002
    Event Type
    Injury
    Date Received
    November 23, 2018
    Date of Event
    February 2, 2018
    Report Date
    November 23, 2018
    Manufacturer
    VOCO GMBH
    Product Code
    LBH
    PMA / PMN Number
    K080814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALLERGIC REACTIONS, SUCH AS SWELLING AND INCREASED TEMPERATURE, CANNOT BE EXCLUDED IN INDIVIDUAL CASES. THE INSTRUCTIONS FOR USE CONTAIN APPROPRIATE WARNINGS. IN CASE OF PROBLEMS, THE TREATMENT MUST BE STOPPED AND THE FLUORIDE VARNISH REMOVED. THE CURRENT CONDITION OF THE PATIENT IS NOT KNOWN. THE RESULTS OF THE ALLERGY TESTS ARE NOT AVAILABLE. THE PATIENT'S REACTIONS WERE NOT CLASSIFIED AS SEVERE BY THE DENTIST. IT IS UNLIKELY THAT VOCO PROFLUORID VARNISH CAUSED THE PATIENT'S ONGOING DISCOMFORT. IT IS POSSIBLE THAT THESE SYMPTOMS ARE DUE TO INTOLERANCE TO CETIRIZINE DIHYDROCHLORIDE OR OTHER MEDICATIONS. HOWEVER, IT IS POSSIBLE THAT THE USE OF VOCO PROFLUORID VARNISH CONTRIBUTED TO THE EVENT. IN CASE OF DOUBT, THEREFORE, A REPORTABLE EVENT IS ASSUMED. (B)(4).

    Description of Event or Problem · 1

    INCIDENT DESCRIPTION WE RECEIVED FROM THE DENTIST: "REACTION DESCRIPTION: PATIENT'S MUM RANG THE PRACTICE ON (B)(6) 2018. SHE EXPLAINED THE PATIENT HAD SWELLING OF HIS LIPS AND FACE AND HAD A TEMPERATURE SINCE THE VARNISH HAD BEEN APPLIED. THE INGREDIENTS OF THE VARNISH WERE EMAILED OVER TO MUM AND DISCUSSED THOROUGHLY OVER THE TELEPHONE. MUM HAD MADE AN APPOINTMENT LATER IN THE DAY TO SEE THE GP. THE VARNISH WAS REMOVED FROM USE. MUM RANG US BACK ON (B)(6) 2018. GP HAD REFERRED THE PATIENT FOR ALLERGY TESTING AND PATIENT WAS NOW TAKING CETIRIZINE DIHYDROCHLORIDE. SPOKE AGAIN WITH MUM ON (B)(6) 2018. THE PATIENT IS STILL UNWELL AND MUM SAID HE IS NOT RIGHT AND HIS ALLERGIES SEEM TO HAVE ESCALATED SINCE THE LAST TIME WE SPOKE. THERE WAS A TRIP A FEW WEEKS AGO TO A&E WHEN THE PATIENT COMPLAINED HIS BREATHING HURT, NO DIAGNOSIS OR FURTHER MEDICATION WAS GIVEN TO THE PATIENT. THERE IS NOW A WHEEZE SIMILAR TO AN ASTHMA WHEEZE PRESENT. THIS IS "EFFECTING" THE PATIENT'S SLEEP AND HE IS TIRED IN THE DAY WHICH IS CAUSING HIS BEHAVIOUR TO CHANGE. MUM SAYS HE IS NOW NAUGHTY AND THIS WASN'T HOW HE WAS BEFORE (B)(6). I ASKED MUM IF THE PATIENT TAKES ANY REGULAR MEDICATION; MUM SAID NO. I ASKED MUM IF THE PATIENT HAD RECEIVED ANY VACCINATIONS IN THE LAST 3 MONTHS; MUM SAID THE PATIENT HAD A 3 YEAR BOOSTER AT THE LOCAL GP ON (B)(6) 2018. AN APPOINTMENT HAS BEEN MADE AT THE HOSPITAL FOR ALLERGY TESTING NEXT MONTH. MUM HAS SAID SHE WILL KEEP US POSTED. THE PATIENT WAS TAKING VOCO FLUORIDE VARNISH CHERRY FOR: DENTAL CARIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939568 VOCO PROFLUORID VARNISH VOCO PROFLUORID VARNISH LBH VOCO GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention