BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)

    MDR report key: 22968235 · Received September 4, 2025

    Report

    Report Number
    3005113652-2025-00788
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    August 18, 2025
    Report Date
    September 4, 2025
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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. 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. THE EVENT OF RESPIRATORY TRACT INFECTION, DEEMED NOT DEVICE RELATED IS CONSIDERED AN UNEXPECTED ADVERSE DRUG EXPERIENCE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT WITH 2CC OF JUVÉDERM® VOLUMA® XC IN THE CHEEKS AND 0.5CC OF JUVÉDERM® VOLBELLA® XC IN THE LIPS. PATIENT IS EXPERIENCING "DELAYED NODULES". HCP LATER REPORTED ABOUT 2 MONTHS POST INJECTION, PATIENT SYMPTOMS STARTED "AS SMALL, SLIGHTLY PALPABLE, MILDLY TENDER NODULE IN UPPER RIGHT LIP AND MILD SWELLING UNDER RIGHT EYE IN MIDFACE AREA. PROGRESSED TO MODERATE TO SEVERE SWELLING OF THE ENTIRE UPPER LIP AND UNDER BOTH EYES/MID CHEEK AREA". TWO DAYS POST SYMPTOM ONSET, PATIENT WAS TREATED WITH DOXYCYCLINE 100MG PO BID X 14 DAYS AND PREDNISONE 20MG PO ONCE DAILY X 5 DAYS. HCP LATER REPORTED THE PATIENT EXPERIENCED A NON-DEVICE RELATED SINUS INFECTION AROUND THE TIME OF THE ONSET OF EDEMA. SYMPTOMS ARE ONGOING. THIS WAS THE INITIAL USE OF THE SYRINGE. THE PACKAGED NEEDLE WAS USED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER ABBVIE COMPLAINT (B)(6),(EMDR-(B)(4). THIS MDR IS BEING SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM® VOLUMA® XC. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER EMDR- 101751. THIS EMDR IS BEING SUBMITTED FOR THE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2094590 JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention