BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLLURE XC 2X1 ML

    MDR report key: 8229026 · Received January 8, 2019

    Report

    Report Number
    3005113652-2018-01830
    Event Type
    Injury
    Date Received
    January 8, 2019
    Date of Event
    September 15, 2018
    Report Date
    January 8, 2019
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    10888628034471
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF "HARD, TENDER NODULES WITH SLIGHT TENDERNESS WHEN PRESSURE APPLIED" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY DEVIATIONS OR NON-CONFORMANCES ARE FOUND, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH JUVÉDERM VOLLURE¿ XC IN THE VERMILLION LIPS AND ORAL COMMISSURES. FIVE MONTHS AFTER INJECTION THE PATIENT EXPERIENCED HARD, TENDER NODULES WITH "SLIGHT TENDERNESS WHEN PRESSURE APPLIED" THROUGHOUT THE MUCOSA. PATIENT WAS TREATED WITH VITRASE INJECTION AND MINOCYCLINE 100MG. SYMPTOMS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20617 JUVEDERM VOLLURE XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V17LA70844 10888628034471

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention