BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTRINGEDENT

    MDR report key: 2282116 · Received September 30, 2011

    Report

    Report Number
    1718912-2011-00006
    Event Type
    Injury
    Date Received
    September 30, 2011
    Date of Event
    September 7, 2011
    Report Date
    September 30, 2011
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Product Code
    LMG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    (B)(4) DID GET ASTRINGEDENT IN HER EYE, BUT SHE LEFT AROUND LUNCH TIME TO URGENT CARE. SHE DID FLUSH HER EYE WITH WATER EVENT THOUGH THEY DON'T HAVE AN EYE WASH SYSTEM IN THEIR OFFICE. SHE SAID HER EYE WAS GLOSSY AND RED. FAXED (B)(4) TO THE OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASTRINGEDENT HEMOSTATIC MEDIA LMG ULTRADENT PRODUCTS, INC. 112 B5KC2

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O