BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC TSK US

    MDR report key: 1980210 · Received February 1, 2011

    Report

    Report Number
    3005113652-2011-00001
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    November 26, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2011.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THAT AN UNSPECIFIED PERIOD OF TIME AFTER INJECTION WITH JUVEDERM ULTRA XC IN "THE TEAR TROUGH AREA" THE PT "COMPLAINED OF EXCESSIVE TEARING." ADD'L INFO: THE PT WAS INJECTED WITH VITRASE TO PREVENT THE WORSENING OF THE SYMPTOMS THAT MAY LEAD TO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA XC TSK US LMH ALLERGAN NA H24L538969

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention