BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 3911610 · Received May 27, 2014

    Report

    Report Number
    3005113652-2014-00218
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENTS "BRUISING", "SWELLING", "FIRM AND LUMPY", "WARM TO THE TOUCH", AND "CELLULITIS" ARE PHYSIOLOGICAL COMPLICATION 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 AFTER INJECTION WITH JUVEDERM ULTRA PLUS XC IN THE NASOLABIAL FOLDS, THE PATIENT EXPERIENCED "BRUISING INITIALLY: AFTER INJECTION, AT THE INJECTION SITE, AND APPROXIMATELY TWENTY DAYS LATER EXPERIENCED INTERMITTENT "SWELLING" ON THE LIPS, AND "SWELLING" ALONG THE NASOLABIAL FOLDS AND CHEEKS. THE PATIENT'S NASOLABIAL FOLDS WERE ALSO "FIRM AND LUMPY" AND "WARM TO THE TOUCH". ZYRTEC, VITRASE, AND KEFLEX WERE PRESCRIBED; SYMPTOMS RESOLVED APPROXIMATELY TWO WEEKS AFTER THE KEFLEX WAS PRESCRIBED. THE HEALTHCARE PROFESSIONAL WAS NOT SURE IF THERE HAD BEEN "CELLULITIS" AND DID NOT BELIEVE THE ETIOLOGY OF THE PATIENT'S SYMPTOMS COULD BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311422 JUVEDERM ULTRA PLUS XC TSK US LMH ALLERGAN H30LA.0288

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention