BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1 ML SKU1

    MDR report key: 3850572 · Received May 22, 2014

    Report

    Report Number
    3005113652-2014-00250
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 19, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 OF EDEMA, ERYTHEMA, AND ITCHING 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 AN UNSPECIFIED SITE WITH JUVEDERM VOLUMA WITH LIDOCAINE THE PATIENT DEVELOPED REDNESS, EDEMA, AND ITCHING ON THE RIGHT CHEEK AND ON THE LEFT CHEEK THE FOLLOWING DAY. PATIENT WAS TREATED WITH AUGMENTIN AND SOLUPRED. SYMPTOMS RESOLVED 6 DAYS AFTER INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306921 JUVEDERM VOLUMA WITH LIDOCAINE 1 ML SKU1 LMH ALLERGAN NA VB20A30331

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention