BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1 ML SKU1

    MDR report key: 4223540 · Received October 29, 2014

    Report

    Report Number
    3005113652-2014-00611
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE EVENTS OF "MASSIVE LYMPH EDEMA," SWELLING, AND HARD NODULES 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 4.5 MONTHS AFTER INJECTION TO THE CHEEKS WITH JUVEDERM VOLUMA WITH LIDOCAINE AS WELL AS CONCOMITANT INJECTION TO THE LIPS WITH JUVEDERM ULTRA SMILE PT DEVELOPED "MASSIVE SWELLING OF CHEEKS, CHIN, AND LOWER LIP," "MASSIVE LYMPH EDEMA,: AND HARD NODULES ON THE "RIM OF ORBITA AND JAWBONE." PT WAS TREATED WITH PREDNISONE AND AUGMENTIN AFTER WHICH SOFT TISSUE EDEMA RESOLVED. THE HARD NODULES DECREASED OVER TIME, RESOLVING APPROX TWO MONTHS AFTER ONSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692717 JUVEDERM VOLUMA WITH LIDOCAINE 1 ML SKU1 LMH ALLERGAN NA VB20A30266

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention JUVEDERM ULTRA SMILE