BEUDAMED
    FDA Adverse Event Summary report: N

    VISCOSTAT CLEAR

    MDR report key: 3032585 · Received April 1, 2013

    Report

    Report Number
    1718912-2013-00001
    Date Received
    April 1, 2013
    Date of Event
    February 12, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ULTRADENT PRODUCTS
    Product Code
    MVL
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    WHEN THE DENTAL ASSISTANT WAS FILLING UP A 1.2 SYRINGE WITH THE 30ML, SHE TOOK OFF THE 1.2 SYRINGE AND A SMALL AMOUNT OF VISCOSTAT FLOW UP UNDER HER SAFETY GLASSES INTO HER EYE. SHE FLUSHED HER EYE FOR 5-10 MINUTES. CORNER OF HER EYE WAS A LITTLE WHITE. THE ASSISTANT IS FINE NOW. IT WAS SUGGESTED THAT THEY USED SAFETY GLASSES THAT WRAP AROUND TO AVOID ANY POSSIBILITY OF THIS HAPPENING IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133704 VISCOSTAT CLEAR TISSUE MANAGEMENT MVL ULTRADENT PRODUCTS 6408 B7NG3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other