BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISCOSTAT BASIC INDISPENSE KIT

    MDR report key: 2163683 · Received June 16, 2011

    Report

    Report Number
    1718912-2011-00003
    Event Type
    Other
    Date Received
    June 16, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ULTRADENT PRODUCTS
    Product Code
    LMG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AN ASSOCIATE DENTIST WHO WAS HANDLING THE SYRINGE PUSHED ON THE PLUNGER, THE VISCOSTAT SOLUTION SHOT OUT OF THE SYRINGE AND INTO THE EYES OF AN ASSISTANT. SHE WAS NOT WEARING PROTECTIVE EYE GEAR. THEY IMMEDIATELY STARTED RINSING HER EYES OUT WITH WATER FOR APPROX 20-30 MINUTES, THEN HAD HER DRIVEN TO THE HOSP EMERGENCY ROOM. THE EMERGENCY ROOM THEN CONTACTED ULTRADENTS CUSTOMER SERVICE FOR THE MSDS SHEET FOR VISCOSTAT SOLUTION. THE EMERGENCY ROOM CONTINUED WITH THE RINSE AND ADMINISTERED MEDICINE. THE PT HAS 1ST DEGREE BURNS ON HER LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISCOSTAT BASIC INDISPENSE KIT VISCOSTAT LMG ULTRADENT PRODUCTS 646 B54M5

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization