BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPAL SEAL

    MDR report key: 2255248 · Received September 12, 2011

    Report

    Report Number
    1718912-2011-00004
    Event Type
    Other
    Date Received
    September 12, 2011
    Date of Event
    August 17, 2011
    Report Date
    September 9, 2011
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Product Code
    DYH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS PRESSING THE PLUNGERS ON OPAL SEAL WITH A NEW TIP AND THE FIBERS SHOT OUT AND OPAL SEAL ENDED UP ON THE DOCTOR'S FACE AND IN HIS EYE. HE RINSED HIS EYE, BUT WAS GOING TO HEAD OVER TO AN EYE DOCTOR FOR FURTHER ADVICE. DIRECTED TO THE MSDS FOR INSTRUCTIONS TO RINSE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPAL SEAL NONE DYH ULTRADENT PRODUCTS, INC. 500061 B6723

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization OPAL SEAL