BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLLURE XC 2X1 ML

    MDR report key: 8840721 · Received July 30, 2019

    Report

    Report Number
    3005113652-2019-00575
    Event Type
    Injury
    Date Received
    July 30, 2019
    Report Date
    July 30, 2019
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    10888628034471
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    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 ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY DEVIATIONS OR NON-CONFORMANCES ARE FOUND, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THESE ARE KNOWN POTENTIAL ADVERSE EVENTS ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED TO COMPANY REPRESENTATIVE THAT "POSSIBLY VESSEL MIGHT HAVE BEEN NICKED IN LIP AS THEY HAD TO TREAT THEM WITH ASPIRIN AND WARM COMPRESSES, A FEW DAYS LATER AS IT WAS TURNING WHITE IN THEIR LIP, PLASTIC SURGEON AND MAIN NP HELPED TREAT THE PATIENT¿ AND "THE BOTTOM LIP WAS HARD AND FELT UNCOMFORTABLE TO THE PATIENT AND THEIR TOP LIP WAS UNEVEN¿ AFTER A PATIENT WAS INJECTED IN THE LIPS WITH JUVÉDERM VOLLURE¿ XC. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635997 JUVEDERM VOLLURE XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V17LA80746 10888628034471

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention