BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCO PROFLUORID VARNISH

    MDR report key: 20841409 · Received December 4, 2024

    Report

    Report Number
    8010908-2024-00001
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    November 4, 2024
    Report Date
    December 4, 2024
    Manufacturer
    VOCO GMBH
    Product Code
    LBH
    PMA / PMN Number
    K080814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT HAS REPORTED THAT AFTER APPLYING VOCO PROFLUORID VARNISH MINT, HE HAD AN ALLERGIC REACTION THE FOLLOWING NIGHT: BURNING OF THE MUCOUS MEMBRANES AND SWELLING OF THE LIPS. SYMPTOMS LASTED 6 DAYS. NO HOSPITALISATION OR OTHER TREATMENT WAS REQUIRED. THE BATCH USED IS NOT KNOWN. THE PATIENT HAS MADE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840065 VOCO PROFLUORID VARNISH PROFLUORID VARNISH LBH VOCO GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other