BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOSTAT (PLUS)

    MDR report key: 464795 · Received June 5, 2003

    Report

    Report Number
    1718912-2003-00001
    Event Type
    Injury
    Date Received
    June 5, 2003
    Date of Event
    March 19, 2003
    Report Date
    April 28, 2003
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Product Code
    LMG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DENTIST DID A CROWN PREPARATION ON THE PATIENT. PATIENT SWALLOWED VISCOSTAT PRODUCT WHEN AREA WAS RINSED. THEY EXPERIENCED BURNING SENSATION, SWELLING AND REDNESS OF THROAT. THE PATIENT HAD DIFFICULTY BREATHING. THE PATIENT WAS TREATED WITH BENADRYL, OXYGEN AND IV FLUID AND RELEASED. THE PATIENT RETURNED TO WORK THE NEXT DAY FREE OF COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISCOSTAT (PLUS) HEMOSTATIC AGENT LMG ULTRADENT PRODUCTS, INC. NA 4MXY/VTABC

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| O INFO HAS BEEN REQUESTED.