BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU 1

    MDR report key: 3913233 · Received June 11, 2014

    Report

    Report Number
    3005113652-2014-00267
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADD'L INFO IS AVAILABLE AT THIS TIME. THE EVENT OF EDEMA IS A PHYSIOLOGICAL COMPLICATION 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 2 MONTHS AFTER INJECTION IN THE "TEMPORAL LOBE" WITH JUVEDERM VOLUMA WITH LIDOCAINE, PT DEVELOPED SWELLING TO THE INJECTION SITE. PT WAS TREATED WITH ICE, "SOLU-DECORTIN AND CEPHACLOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343842 JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU 1 LMH ALLERGAN NA VB20A30298

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention JUVEDERM VOLBELLA WITH LIDOCAINE IN THE LIPS AND,| JUVEDERM VOLIFT WITH LIDOCAINE IN THE CHEEKS