BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC/LIDO (VOLUME UNK)

    MDR report key: 4142539 · Received October 1, 2014

    Report

    Report Number
    3005113652-2014-00479
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 5, 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 SWELLING AND LUMPS 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 TEN MINUTES AFTER INJECTION WITH JUVEDERM VOLUMA XC IN THE "LOWER FACE" AND "PERIORAL AREA" AS WELL AS CONCOMITANT INJECTION OF JUVEDERM VOLIFT WITH LIDOCAINE IN THE ORAL COMMISSURES, THE PATIENT DEVELOPED SWELLING AND LUMPS AT THE ORAL COMMISSURES. PATIENT WAS TREATED WITH HYALASE AND PRESCRIBED KEFLEX. SYMPTOMS RESOLVED THE DAY AFTER INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611579 JUVEDERM VOLUMA XC/LIDO (VOLUME UNK) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention BOTOX, JUVEDERM VOLIFT WITH LIDOCAINE