BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1 ML

    MDR report key: 4223555 · Received October 29, 2014

    Report

    Report Number
    3005113652-2014-00560
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 8, 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 INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE EVEN OF A HYPERSENSITIVITY REACTION INVOLVING HARD, SWOLLEN, SORE INJECTION SITES AND FLUID RETENTION ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT THE DAY AFTER INJECTION TO THE MIDFACE WITH JUVEDERM VOLUMA XC, THE PT DEVELOPED SWELLING. UPON REVIEW THE HEALTHCARE PROFESSIONAL OBSERVED THAT THE "TREATED AREAS WERE VERY HARD AND SWOLLEN" AND BELIEVED THE PT'S SYMPTOMS WERE DUE TO A "REACTION OR HYPERSENSITIVITY TO THE DERMAL FILLER/REJECTION." THE PT WAS TREATED WITH "HYLASE," "ANTIBIOTICS" AND PREDNISONE. "TISSUES IN TREATED AREA ARE STILL HARD, SWOLLEN AND SORE. EYES ARE STILL SWOLLEN WITH FLUID RETENTION." THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID # 3005113652-2014-00559 (ALLERGAN COMPLAINT # (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, JUVEDERM VOLUMA XC, ALSO A DEVICE MANUFACTURED BY ALLERGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692797 JUVEDERM VOLUMA WITH LIDOCAINE 1 ML LMH ALLERGAN NA VB20A40132

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention