BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOCO PROFLUORID VARNISH

    MDR report key: 10599443 · Received September 29, 2020

    Report

    Report Number
    8010908-2020-00002
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    September 23, 2020
    Report Date
    September 30, 2020
    Manufacturer
    VOCO GMBH
    Product Code
    LBH
    PMA / PMN Number
    K080814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ONE OF THE HYGIENISTS OPENED A PACKAGE OF CARAMEL FLUORIDE AND SAID IT "EXPLODED UNDER PRESSURE" AND ENDED UP IN HER EYE. SHE SAID SHE WAS WEARING PROTECTIVE EYEWEAR, BUT IT STILL MANAGED TO GET IN HER EYE. SHE WENT TO URGENT CARE TO HAVE HER EYES FLUSHED. SHE IS FINE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062567 VOCO PROFLUORID VARNISH VOCO PROFLUORID VARNISH LBH VOCO GMBH 1936241

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention