BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1

    MDR report key: 4213027 · Received October 24, 2014

    Report

    Report Number
    3005113652-2014-00582
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 INFLAMMATION, "HOLLOW IN THE RIGHT CHEEK" AND "MOVABLE" PRODUCT 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 TO THE CHEEKS WITH JUVEDERM VOLUMA WITH LIDOCAINE PT'S "RIGHT CHEEK WAS INFLAMED AND EYE WAS HALF CLOSED." PT WAS TREATED WITH ANTIBIOTICS AND AN ANTI-INFLAMMATORY, HOWEVER CONTINUES WITH A "HOLLOW IN THE RIGHT CHEEK" AND NOTES "FILLERS APPEARS TO BE PRESENT IN PERIORBITAL AREA AND IS MOVABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678072 JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1 LMH ALLERGAN NA VB20A40180

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention