BEUDAMED
    FDA Adverse Event Other Summary report: N

    VOCO PROFLUORID VARNISH

    MDR report key: 4073095 · Received August 25, 2014

    Report

    Report Number
    8010908-2014-00002
    Event Type
    Other
    Date Received
    August 25, 2014
    Report Date
    August 21, 2014
    Manufacturer
    VOCO GMBH
    Product Code
    LBH
    PMA / PMN Number
    K080814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPHONY-INTOLERANCES CANNOT BE EXCLUDED. SO FAR, WE HAVE NOT REC'D ANY INFO ABOUT ANY REACTIONS TO CERTAIN FLAVORS OR OTHER INGREDIENTS. THE CASE WAS ASSIGNED TO THE DEPARTMENT OF COMPLAINTS AND DOCUMENTED. NO REPORTS HAVE BEEN REC'D REGARDING OTHER CASES OF THIS TYPE IN RELATION WITH VOCO PROFLUORID VARNISH. AT THIS TIME, NO FURTHER MEASURES ARE PLANNED ON THIS CASE.

    Description of Event or Problem · 1

    A DENTIST ALLEGED THAT SHE AND TWO PATIENTS HAVE HAD AN ADVERSE REACTION TO PERFLUORID VARNISH. THE DENTIST AND ONE OF THE PATIENTS HAD SWOLLEN LIPS AND TONGUES, ITCHING AND BURNING. THE THROAT OF THE SECOND PATIENT SWELLED UP AND SHE CHOSE TO GO TO HOSPITAL FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511180 VOCO PROFLUORID VARNISH NONE LBH VOCO GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization