BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFLUORID L SD

    MDR report key: 25241515 · Received May 21, 2026

    Report

    Report Number
    8010908-2026-00002
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 21, 2026
    Manufacturer
    VOCO GMBH
    Product Code
    LBH
    UDI-DI
    E2210069000000000FY
    PMA / PMN Number
    K083036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUCTIONS FOR USE STATE THAT THE SYMPTOMS DESCRIBED MAY OCCUR IF THE PRODUCT IS USED INCORRECTLY OR IN EXCESSIVE AMOUNTS. "...INCORRECT APPLICATION (SEE SECTION ENTITLED "METHOD OF USE") CAN RESULT IN LARGER AMOUNTS OF FLUORIDE BEING INTRODUCED INTO THE ORAL CAVITY THAN INTENDED. SWALLOWING SUCH AN AMOUNT CAN LEAD TO NAUSEA, VOMITING AND/OR DIARRHOEA..." PROFLUORID L CONTAINS ETHYL ACETATE, SODIUM FLUORIDE, CALCIUM FLUORIDE, CELLULOSE ESTER AND EUGENOL. DO NOT USE IN CASE OF KNOWN ALLERGIES TO INGREDIENTS. THERE ARE NO KNOWN SIMILAR INCIDENTS ASSOCIATED WITH PROFLUORID L.

    Description of Event or Problem · 0

    A PATIENT WAS TREATED WITH PROFLUORID L FOR SENSITIVE TOOTH NECKS IN THE UPPER AND LOWER JAWS AND WAS DISCHARGED WITHOUT ANY SIDE EFFECTS. THE PATIENT REPORTS HAVING SUFFERED FROM NAUSEA, VOMITING, AND HEADACHES IMMEDIATELY AFTER TREATMENT WITH PROFLUORID L. SHE FELT UNABLE TO DRIVE AND CONSULTED A DOCTOR. THE ATTENDING PHYSICIAN SUGGESTED THAT AN OVERDOSE OF FLUORIDE MIGHT BE THE CAUSE OF HER SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100559 PROFLUORID L SD BIFLUORID 10 SINGLEDOSE LBH VOCO GMBH 2449131 E2210069000000000FY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other