BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCO PROFLUORID VARNISH

    MDR report key: 9591559 · Received January 15, 2020

    Report

    Report Number
    8010908-2020-00001
    Event Type
    Injury
    Date Received
    January 15, 2020
    Date of Event
    January 9, 2020
    Report Date
    January 15, 2020
    Manufacturer
    VOCO GMBH
    Product Code
    LBH
    PMA / PMN Number
    K080814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON THE BASIS OF THE INFORMATION AVAILABLE,WE SHARE THE DENTIST OPINION THAT THE PATIENT'S SYMPTOMS WERE PROBABLY NOT CAUSED BY TREATMENT WITH PROFLUORID VARNISH. VPV CONTAINS COLOPHONY. ALLERGIC REACTIONS CANNOT BE EXCLUDED IN INDIVIDUAL CASES. HOWEVER, BECAUSE THE PATIENT NEEDED MEDICAL INTERVENTION AND IT CANNOT BE EXCLUDED THAT VPV CONTRIBUTED TO THE INCIDENT, WE PRECAUTIONARY REPORT THE INCIDENT TO THE FDA IN ACCORDANCE WITH 21 CFR 803. FURTHER ACTION ARE NOT REQUIRED.

    Description of Event or Problem · 1

    MOTHER OF (B)(6)YO FEMALE PATIENT, WITH NO KNOWN ALLERGIES/ NO CURRENT MEDICAL CONDITIONS CALLED THE DENTISTS OFFICE ON 10-JAN-2020 REPORTING "AN ANAPHYLACTIC REACTION TO THE VARNISH" FROM THE CLEANING APPOINTMENT HER CHILD HAD ON THURSDAY ((B)(6) 2020). SHE SAID THE CHILD COMPLAINED OF A SORE/ BURNING THROAT ON THE WAY HOME. THE PATIENT HAD A TYPICAL EXAM, PROPHYLAXIS AND VPV WAS PLACED. THE PATIENT HAD BEEN TREATED ONCE PRIOR TO THIS APPOINTMENT IN THE OFFICE (PROPHYLAXIS) WITHOUT ISSUE. A PHOTO WE RECEIVED ON FRIDAY (10-JAN-2020) AFTERNOON SHOWS SWOLLEN LESIONS IN THE TONSIL/ THROAT AREA. NO PHOTO WAS TAKEN OF THE GINGIVA, LIPS, TONGUE OR BUCCAL MUCOSA. THE PATIENT NEVER COMPLAINED OF PAIN WHILE IN THE OFFICE OR AS THE VPV WAS PLACED. THERE WAS NO FEVER AND NO ISSUES BREATHING. THE HYGIENIST/ DOCTOR WAS UNAWARE OF ANY ISSUE UNTIL THE FOLLOWING DAY (FRIDAY 10-JAN-2020). THE MOTHER THEN REPORTED TO THE OFFICE THAT THE CHILD SAW AN ORAL SURGEON, WHO WAS A NEIGHBOR, AND HE SUGGEST IT WAS A REACTION TO THE VPV. THE MOTHER THEN TOOK THE PATIENT TO THE PAEDIATRICIAN WHO DIAGNOSED THE PATIENT WITH ALLERGIES. THE PATIENT WAS PRESCRIBED STEROIDS BY THE PAEDIATRICIAN. ON 14-01-2020 THERE WAS A REPORT TO THE PRACTICE STAFF THE BROTHER NOW PRESENTS WITH THE SAME LESIONS. THE DENTIST FEELS THIS IS A VIRAL/ BACTERIAL INFECTION AND NOT ASSOCIATED WITH THE VARNISH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55471 VOCO PROFLUORID VARNISH PROFLUORID VARNISH LBH VOCO GMBH 1814071

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other