BEUDAMED
    FDA Adverse Event Summary report: N

    VOCO PROFLUORID VARNISH

    MDR report key: 6154096 · Received December 8, 2016

    Report

    Report Number
    8010908-2016-00002
    Date Received
    December 8, 2016
    Date of Event
    August 30, 2016
    Report Date
    December 8, 2016
    Manufacturer
    VOCO GMBH
    Product Code
    LBH
    PMA / PMN Number
    K080814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE PRODUCT IN QUESTION COULD NOT BE PERFORMED. THE PRODUCT WAS NOT RETURNED TO US. LOT-NUMBER AND EXPIRY DATE ARE UNKNOWN. THE CASE WAS ASSIGNED TO THE DEPARTMENT OF COMPLAINTS AND DOCUMENTED. NO FURTHER MEASURES ARE PLANNED ON THIS CASE. COLOPHONY-INTOLERANCES CANNOT BE EXCLUDED, ESPECIALLY FOLLOWING APPLICATION TO EXTENSIVE SURFACES LIKE THIS CASE. THE INSTRUCTIONS FOR USE CONTAIN APPROPRIATE WARNINGS. (B)(4).

    Description of Event or Problem · 1

    THE (B)(4) AGENCY HAS RECEIVED A REPORT FROM A (B)(6) HEALTHCARE PROVIDER REGARDING AN INCIDENT WITH VOCO PROFLUORID VARNISH. THE INCIDENT CONCERNS A PATIENT WITH SIDE EFFECTS SUCH AS SWELLING AND ITCHING AFTER TREATMENT WITH PROFLUORID VARNISH. THE MEDICAL PRODUCTS AGENCY REQUESTS U.S. TO SUBMIT A VIGILANCE REPORT FROM THE MANUFACTURER TO THE MEDICAL PRODUCTS AGENCY IN ACCORDANCE WITH (B)(4) REGULATION. VOCO PROFLUORID VARNISH IS MARKETED IN U.S. ;THEREFORE, THE EVENT IS REPORTABLE ACCORDINGLY 21CFR 803. INCIDENT DESCRIPTION RECEIVED BY DENTIST: DENTIST TREATED THE PATIENT WITH FLUORIDE VARNISH GENERALLY, ON EVERY TOOTH ON THE 30/8. A WEEK LATER, HIS MOTHER WAS AT THE CLINIC AND TOLD HIM THAT THE BOY HAD AN ALLERGIC REACTION IN THE EVENING/NIGHT AND REACTED WITH ITCHING/SORE/SWELLING IN THE MOUTH AND ON THE LIPS. THE PARENTS COULD NOT CONNECT THE REACTION TO ANYTHING ELSE BUT THE FLUORIDE VARNISH. THE PATIENT IS FULLY RECOVERED. THERE IS NO SEVERE MEDICAL IMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806871 VOCO PROFLUORID VARNISH VOCO PROFLUORID VARNISH LBH VOCO GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization