BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLITE WITH LIDOCAINE 2X1 ML

    MDR report key: 23292409 · Received October 15, 2025

    Report

    Report Number
    3005113652-2025-00906
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 26, 2017
    Report Date
    October 14, 2025
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO H.6. TYPE OF INVESTIGATION CODE: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH JUVÉDERM® VOLIFT¿ WITH LIDOCAINE. PATIENT EXPERIENCED SWELLING A FEW WEEKS POST INJECTION AND WAS TREATED WITH HYALURONIDASE. 5 YEARS LATER, PATIENT WAS INJECTED AGAIN WITH 0.5ML IN EACH TEAR TROUGH WITH JUVÉDERM® VOLITE¿. PATIENT DEVELOPED TYNDALL AND EDEMA TO TEAR TROUGH AREA BILATERALLY. PATIENT WAS TREATED WITH HYALURONIDASE AND SYMPTOM RESOLVED. HOWEVER, EDEMA/SWELLING/TINDEL EFFECT SEEMS TO REAPPEAR EVERY 3 MONTHS. SYMPTOM IS ONGOING. THIS RECORD IS FOR JUVÉDERM® VOLITE¿. ADDITIONALLY, THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WAS INJECTED WITH 0.5ML PER TEAR TROUGH, WITH JUVÉDERM® VOLITE¿ THE PATIENT NOTICED A SIGNIFICANT REDUCTION IN DARKNESS AND DEPRESSION OF TEAR TROUGHS. THERE WAS SWELLING TO UPPER AND LOWER EYELIDS AND TEAR TROUGH. THERE WAS A DIAGNOSTIC TEST PERFORMED OF AN X-RAY SINUS. THE RESULTS WERE THAT THE FACIAL SOFT TISSUE MAY BE SWOLLEN, OTHERWISE UNREMARKABLE. PATIENT WAS TREATED MEDICALLY 6 YEARS AGO WITH HYALURONIDASE BY NEEDLE, FOUR YEARS AND 9 MONTHS LATER A TREATMENT OF HYALURONIDASE BY NEEDLE, APPROXIMATELY TWO MONTHS LATER TREATMENT OF HYALURONIDASE BY NEEDLE, 3 WEEKS LATER PATIENT WAS TREATED AGAIN WITH HYALURONIDASE BY NEEDLE. ONE YEAR LATER THE PATIENT WAS TREATED WITH HYALURONIDASE BY NEEDLE, TWO WEEKS AFTER THAT WAS TREATED WITH HYALURONIDASE BY NEEDLE, 2 MONTHS LATER PATIENT WAS TREATED WITH HYALURONIDASE BY NEEDLE, AND 5 MONTHS LATER THE PATIENT WAS TREATED WITH HYALURONIDASE BY NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336923 JUVEDERM VOLITE WITH LIDOCAINE 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY 1000520424

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention