BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK JUVEDERM VOLUX

    MDR report key: 23472015 · Received November 4, 2025

    Report

    Report Number
    3005113652-2025-00991
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 3, 2025
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. ARTICLE CITATION: XIANG, H., WEI, M., YI, P., AO, R., & SUN, Y. (2025). DELAYED INFLAMMATION OCCURRED ONLY TO VYC-25L AFTER COINJECTION OF VYC-20L AND VYC-25L IN AN ASIAN PATIENT. PLASTIC AND RECONSTRUCTIVE SURGERY - GLOBAL OPEN, 13(10). HTTPS://DOI.ORG/10.1097/GOX.0000000000007211. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ABBVIE HAS RECEIVED NO RESPONSE FROM THE AUTHORS. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    VIA THE ARTICLE ¿DELAYED INFLAMMATION OCCURRED ONLY TO VYC-25L AFTER COINJECTION OF VYC-20L AND VYC-25L IN AN ASIAN PATIENT," A HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN THE MANDIBULAR ANGLE AND CHIN WITH 5 ML OF JUVÉDERM® VOLUX® AND IN THE CHEEKS WITH 2 ML OF JUVÉDERM® VOLUMA® WITH LIDOCAINE. APPROXIMATELY 1 MONTH LATER, THE PATIENT EXPERIENCED ¿MILD REDNESS¿ IN THE CHIN THAT WAS NOT APPARENT UNDER NATURAL LIGHT. AN MRI WAS PERFORMED THAT SHOWED NO OBVIOUS SIGNS OF LOCAL INFLAMMATION OR SOFT TISSUE EDEMA. THE FILLER WAS VISIBLE IN THE CHIN AREA WITH NO SIGNS OF INFLAMMATION OR EDEMA. THE EVENT WAS SUSPECTED TO BE DUE TO ¿EXCESSIVE SKIN TENSION IN THE CHIN THAT RESULTED IN HYPERACTIVITY OF THE MENTALIS MUSCLE.¿ BOTOX® WAS INJECTED INTO THE MENTALIS MUSCLE TO INTRODUCE RELAXATION AND TO ELEVATE THE JAWLINE. THE ¿REDNESS¿ GRADUALLY SUBSIDED DURING THE SUBSEQUENT MONTH. ON DAY 70, THE PATIENT UNDERWENT DENTAL RESTORATION AND PERIODONTAL SCALING. THE NEXT DAY, THE PATIENT REPORTED ¿REDNESS, SWELLING, AND INCREASED SKIN TEMPERATURE¿ IN THE CHIN AREA. TWO DAYS LATER, BLOOD TESTS AND C-REACTIVE PROTEIN (CRP) LEVELS WERE OBTAINED, REVEALING NORMAL WHITE BLOOD CELL COUNTS AND CRP VALUES. THE PATIENT TOOK CEPHALOSPORIN ANTIBIOTICS AND TINIDAZOLE PROPHYLACTICALLY, BUT THE CHIN INFLAMMATION INTENSIFIED OVER THE FOLLOWING WEEK, WITH THE ONSET OF PAIN AND MOUTH-OPENING LIMITATION. TEN DAYS AFTER THE DENTAL PROCEDURE (DAY 80), THE PATIENT RETURNED DUE TO AGGRAVATED SWELLING AND PAIN. MRI IMAGING SHOWED SIGNIFICANT CHIN EDEMA AND SIGNS OF INFLAMMATION COMPARED WITH THE PRIOR ONE, WITH NO ADVERSE FINDINGS IN THE CHEEK REGION. THE PATIENT WAS TREATED WITH 450 U OF HYALURONIDASE. WITHIN 24 HOURS, THE PAIN, SWELLING, AND MOUTH-OPENING LIMITATION WERE SIGNIFICANTLY RELIEVED. SEVEN DAYS LATER, THE SWELLING HAD NEARLY DISAPPEARED, AND PAIN AND MOUTH-OPENING LIMITATION HAD COMPLETELY RESOLVED. THE CHIN WAS SMOOTH WITH NO PALPABLE NODULES. ADDITIONALLY, THE PROJECTION OF THE CHIN REMAINED IMPROVED COMPARED WITH THE BASELINE. THIS FILE CAPTURED THE JUVÉDERM® VOLUX®.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2575297 UNK JUVEDERM VOLUX IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY NI

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Required Intervention