BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK JUVEDERM VOLITE

    MDR report key: 23785286 · Received December 11, 2025

    Report

    Report Number
    3005113652-2025-01132
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 11, 2025
    Report Date
    December 11, 2025
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION 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 · 0

    HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED WITH JUVÉDERM VISTA VOLITE XC IMMEDIATELY AFTER SURGERY PATIENT EXPERIENCED SEVERE PAIN IN THE RIGHT CHEEK. FOUR DAYS LATER, PATIENT EXPERIENCED BLEEDING ON THE RIGHT CHEEK, SLIGHT BRUISING AND DRY SKIN AND PORES. TWO DAYS LATER, EXPERIENCED WORSENING OF THE RIGHT CHEEK'S COLOR AND NEXT DAY REDNESS WITH PRESSURE, SWELLING AND DECREASED SENSATION. 240 UNITS OF HYALURONIDASE WERE INJECTED EXCLUSIVELY INTO THE AREA WITH DISCOLORATION. CEFCAPENE PIVOXIL WAS ALSO PRESCRIBED ORALLY. VISIT 10 OTHER HOSPITALS, PRESCRIBED ORAL TRAMXAMIC ACID INTRODUCED ANTI-INFLAMMATORY COCKTAIL AT LDM. CONTINUE ORAL TRAMXAMIC ACID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627089 UNK JUVEDERM VOLITE IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY NI

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention