BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)

    MDR report key: 3812805 · Received May 6, 2014

    Report

    Report Number
    3005113652-2014-00185
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 9, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAVE BEEN REQUESTED. HEALTHCARE PROFESSIONAL INDICATED THEY DID NOT RECORD THE LOT NUMBER. THE EVENTS OF FIRMNESS, TENDERNESS, AND SWELLING 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 3 MONTHS AFTER INJECTION WITH EIGHT SYRINGES OF JUVEDERM VOLUMA WITH LIDOCAINE IN THE TEAR TROUGHS, CHEEKS, LOWER FACE, AND JOWLS, PATIENT EXPERIENCED FIRMNESS, TENDERNESS, AND SWELLING IN THE LOWER FACE, INCLUDING THE MENTUM, CHEEKS, AND LIPS. PATIENT WAS TREATED WITH HYALURONIDASE AND PREDNISONE; AND SYMPTOMS RESOLVED APPROXIMATELY 3.5 WEEKS AFTER ONSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271434 JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) LMH ALLERGAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention