BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK JUVEDERM VOLUMA

    MDR report key: 3925621 · Received June 17, 2014

    Report

    Report Number
    3005113652-2014-00270
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT OR PATIENT DETAILS HAVE BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE VENTS OF PRODUCT MIGRATION AND LUMPS 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 AFTER INJECTION IN UNSPECIFIED LOCATIONS WITH JUVEDERM VOLUMA AND JUVEDERM VOLIFT WITH LIDOCAINE, THE PRODUCT "TRACKED UP TO BELOW THE [PATIENT'S] LATERAL INFRA-ORBITAL RIM" AND A SMALL VISIBLE LUMP DEVELOPED IN THE TEAR TROUGH AREA. PATIENT WAS TREATED WITH "ANTIBIOTICS" AND PREDNISOLONE "WITH SOME EFFECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355772 UNK JUVEDERM VOLUMA LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention JUVEDERM VOLIFT WITH LIDOCAINE