BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCO PROFLUORID VARNISH

    MDR report key: 16425510 · Received February 23, 2023

    Report

    Report Number
    8010908-2023-00001
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    January 31, 2023
    Report Date
    February 21, 2023
    Manufacturer
    VOCO GMBH
    Product Code
    LBH
    PMA / PMN Number
    K080814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VOCO PROFLUORID VARNISH HAS NO POTENTIAL TO CAUSE THE DESCRIBED DAMAGE TO THE GINGIVA DUE TO ITS COMPOSITION AND CONCENTRATION OF INGREDIENTS. NO SIMILAR CASES ARE KNOWN. THE PRODUCT SENT IN AND THE PRODUCTION RECORDS WERE CHECKED. THERE IS NO PRODUCT DEFECT. THE CASE IS EVALUATED AS AN INDIVIDUAL CASE THAT WAS MOST LIKELY NOT CAUSED BY VOCO PROFLUORIDE VARNISH.

    Description of Event or Problem · 0

    ACCORDING TO THE DENTIST, A PARODONTOSIS PATIENT UNDERWENT PROPHYLAXIS WITH ULTRASOUND, POLISHING WITH POLISHING PASTE FROM KERR HAWE AND SUBSEQUENT APPLICATION OF VOCO PROFLUORID VARNISH IN (B)(6) FRONT 41/31. THE PATIENT HAD NO ACUTE INFLAMMATION OR SYMPTOMS. AFTER TREATMENT, THE PATIENT HAD EXPERIENCED BURNING AND STINGING OF THE TOOTH AND GUMS. AFTER TWO DAYS, THE PATIENT TELEPHONED TO INQUIRE WHETHER THE PAIN WAS USUAL AND RETURNED TO THE PRACTICE TWO DAYS LATER. THE GUMS AND TEETH WERE DISCOLORED BROWN AND THE GINGIVA HAD RECEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612238 VOCO PROFLUORID VARNISH VOCO PROFLUORID VARNISH LBH VOCO GMBH 2237060

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Disability