BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1 ML

    MDR report key: 4223539 · Received October 29, 2014

    Report

    Report Number
    3005113652-2014-00559
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    July 31, 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 BRUISING SWELLING, "HOT, HARD, TENDER, AND SENSITIVE" CHEEKS, AND HYPERSENSITIVITY REACTION 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 "A FEW DAYS" AFTER INJECTION TO THE MIDFACE WITH JUVEDERM VOLUMA XC PT DEVELOPED "BRUISING SWELLING, PUFFINESS UNDER EYES" AND "HOT, HARD, TENDER, SENSITIVE" CHEEKS. PT WAS PRESCRIBED KELFLEX BY ANOTHER PHYSICIAN BUT AFTER 5 DAYS "THE SWOLLEN AREA DIDN'T GO DOWN AND AREA WAS STILL WARM AND TENDER." PT WAS TREATED BY INJECTING PHYSICIAN WITH "HYLASE" AND SYMPTOMS RESOLVED APPROX AFTER 2 WEEKS. PHYSICIAN BELIEVES THE EVENT WAS ATTRIBUTED TO A "REACTION OR HYPERSENSITIVITY TO THE DERMAL FILLER/REJECTION." THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID # 3005113652-2014-00560 (ALLERGAN COMPLAINT # (B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVEDERM VOLUMA XC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692789 JUVEDERM VOLUMA WITH LIDOCAINE 1 ML LMH ALLERGAN NA VB20A40132

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention