BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK JUVEDERM VOLUMA

    MDR report key: 3971297 · Received June 30, 2014

    Report

    Report Number
    3005113652-2014-00337
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT 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 48 HOURS AFTER INJECTION IN THE "MALAR REGION" WITH UNSPECIFIED JUVEDERM VOLUMA, THE PT DEVELOPED EDEMA AT THE INJECTION SITE. PT WAS TREATED WITH "CORTICOID AND AN ANTI-INFLAMMATORY" AND HAS "HAD IMPROVEMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378786 UNK JUVEDERM VOLUMA LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention