BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLLURE (VOLUME UNKNOWN)

    MDR report key: 8716102 · Received June 20, 2019

    Report

    Report Number
    3005113652-2019-00452
    Event Type
    Injury
    Date Received
    June 20, 2019
    Date of Event
    October 12, 2017
    Report Date
    June 20, 2019
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED INJECTING A PATIENT IN THE ¿NSL¿ AND MARIONETTE LINES WITH 2 ML OF JUVÉDERM VOLLURE¿ XC. 6 DAYS LATER, THE PATIENT EXPERIENCED ¿NODULES, SEVERE SWELLING AND INFLAMMATION WHEN FLYING AT THE INJECTION SITE, AND THE PRODUCT FELT AS IF IT MOVED AROUND¿. THE PATIENT WAS TREATED WITH HYALURONIDASE 8 DAYS AFTER THE SYMPTOMS FIRST APPEARED, AGAIN 1.5 WEEKS LATER, AGAIN 2 WEEKS LATER, AND AGAIN OVER 2 WEEKS LATER. THE SYMPTOMS HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510485 VOLLURE (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention