BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC 1 ML ROW

    MDR report key: 3841085 · Received May 16, 2014

    Report

    Report Number
    3005113652-2014-00198
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADD'L INFO IS AVAILABLE AT THIS TIME. THE EVENTS OF REDNESS AND ITCHING ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED APPROX ONE WEEK AFTER INJECTION IN THE "MALAR REGION, NASOLABIAL FOLDS AND MENTO REGION" WITH JUVEDERM ULTRA XC, THE PT DEVELOPED ITCHING AND REDNESS AT THE INJECTION SITES. PT WAS TREATED WITH "PREDNISONE AND ALLEGRA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293385 JUVEDERM ULTRA XC 1 ML ROW LMH ALLERGAN NA H24LA30392

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention