BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1 ML

    MDR report key: 4170540 · Received October 9, 2014

    Report

    Report Number
    3005113652-2014-00511
    Event Type
    Injury
    Date Received
    October 9, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 29, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF "HARD LUMPS" AND "HARDENED/THICKENED" AREAS 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 ONE MONTH AFTER INJECTION WITH JUVEDERM VOLUMA WITH LIDOCAINE IN THE "MID FACE" AS WELL AS CONCOMITANT INJECTION OF JUVEDERM VOLBELLA WITH LIDOCAINE "AROUND THE MOUTH, UPPER LIP LINES, AND MENTAL CREASE," THE PATIENT DEVELOPED "HARD LUMPS TO LOWER FACE." THE PATIENT WAS TREATED WITH HYLASE IN THE MARIONETTE LINES. APPROXIMATELY ONE MONTH AFTER SYMPTOM ONSET, THE PATIENT PRESENTED TO THE HEALTHCARE PROFESSIONAL WITH ADDITIONAL "HARDNESS" AT THE JUVEDERM VOLUMA WITH LIDOCAINE AND JUVEDERM VOLBELLA WITH LIDOCAINE INJECTION SITES, INCLUDING BILATERAL "UPPER AND MID MALAR AREAS, MARIONETTES, AND CHIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636859 JUVEDERM VOLUMA WITH LIDOCAINE 1 ML LMH ALLERGAN NA VB20A40132

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention JUVEDERM VOLBELLA WITH LIDOCAINE