BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDAOCAINE 1ML

    MDR report key: 4162869 · Received October 8, 2014

    Report

    Report Number
    3005113652-2014-00494
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 12, 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 HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS "REDNESS, INDURATION, AND PAIN" 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 DAYS AFTER INJECTION IN THE CHEEKS WITH JUVEDERM VOLUMA WITH LIDOCAINE AND CONCOMITANT INJECTION WITH JUVEDERM VOLIFT WITH LIDOCAINE, THE PATIENT DEVELOPED "REDNESS AND INDURATION (OF THE) LEFT CHEEK" WITH PAIN. PATIENT WAS TREATED WITH "ORAL ANTIBIOTIC", FOLLOWED BY "IV ANTIBIOTIC" BUT HAS NOT YET RESPONDED TO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631455 JUVEDERM VOLUMA WITH LIDAOCAINE 1ML LMH ALLERGAN NA VB20A40153

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention JUVEDERM VOLIFT WITH LIDOCAINE IN BOTH CHEEKS