BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISCOSTAT

    MDR report key: 2426237 · Received January 13, 2012

    Report

    Report Number
    1718912-2012-00001
    Event Type
    Other
    Date Received
    January 13, 2012
    Date of Event
    December 15, 2011
    Report Date
    January 13, 2012
    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

    THE PT HAD AN ALLERGIC REACTION. THE PT HAS A KNOWN SENSITIVITY TO SULFA. THE PT IS KNOWN TO HAVE MANY ALLERGIES AND HYPERSENSITIVITIES. THE PT HAD SWELLING IN THE FACE AND LIPS AND SOUGHT MEDICAL ATTENTION AT THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISCOSTAT TISSUE MANAGEMENT LMG ULTRADENT PRODUCTS, INC. 645 B67JT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization