BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)

    MDR report key: 20509467 · Received October 22, 2024

    Report

    Report Number
    3005113652-2024-00655
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    December 8, 2023
    Report Date
    January 30, 2025
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CORRECTED, AND/OR CHANGED DATA: A4, A6, B5, H6, AND H8.

    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: LOPEZ, MIYAHRA HANIKO P., ET AL. ¿POST-HYALURONIC ACID FILLER REACTION TREATED WITH ABROCITINIB: A CASE REPORT.¿ JOURNAL OF DRUGS IN DERMATOLOGY, VOL. 23, NO. 1, PP. 1355¿56. HTTPS://DOI.ORG/10.36849/JDD.7271. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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

    ADDITIONAL INFORMATION REPORTED SYMPTOMS FULLY RESOLVED.

    Description of Event or Problem · 0

    VIA THE ARTICLE "POST-HYALURONIC ACID FILLER REACTION TREATED WITH ABROCITINIB: A CASE REPORT"NOTED A PATIENT WAS INJECTED WITH JUVÉDERM® VOLUMA¿ XC INTO THEIR ZYGOMATIC ARCHES. PATIENT LATER HAD DELAYED ONSET NODULES AND SWELLING ALL OVER THEIR CHEEKS AND JAWLINE. PATIENT UNDERWENT THREE COURSES OF ORAL ANTIBIOTICS INCLUDING CEPHALEXIN, AMOXICILLIN CLAVULANATE, AND CLARITHROMYCIN AS WELL AS SEPARATE WEEK LONG COURSES OF A METHYLPREDNISOLONE TAPER. PATIENT REPORTEDLY EXPERIENCED IMPROVEMENT FOLLOWING THE STEROID COURSES, BUT REBOUND SWELLING UPON COMPLETION OF EACH. PATIENT ALSO HAD 5 HYALURONIDASE INJECTIONS DURING THIS TIME IN WHICH SOME, BUT NOT ALL, OF THE NODULES SOFTENED AND DECREASED IN SIZE. ORAL ANTIHISTAMINES WERE ALSO TRIED, WITH NO EFFECT. ULTIMATELY, ABOUT SIX WEEKS POST INJECTION, PATIENT PRESENTED TO A DERMATOLOGIST FOR TREATMENT. ERYTHEMATOUS PATCHES ON THE BILATERAL EYELIDS AND MALAR CHEEKS WERE NOTED WITH MILD SWELLING OF THE ZYGOMATIC ARCHES AND LOWER CHEEKS WITH MULTIPLE FIRM PALPABLE NODULES OF VARYING SIZES IN THE UPPER, MID, AND LOWER CHEEKS. PATIENT ALSO HAD DERMOGRAPHISM AND EYELID SWELLING. BASELINE EXAMINATIONS RULED OUT ACTIVE INFECTION AND PATIENT WAS STARTED ON ABROCITINIB 100MG DAILY, ALLEGRA 180MG TWICE DAILY, AND 0.0005% FLUTICASONE OINTMENT FOR PRURITUS. WITHIN 14 DAYS, PATIENT REPORTED MARKED IMPROVEMENT OF ITCH AND REDUCTION OF SWELLING. AT TWO MONTH FOLLOW UP, THE EDEMA RESOLVED WITH FURTHER IMPROVEMENT TO SOME NODULES AND PRURITUS. THERE WAS VISIBLE REDUCTION IN THE WIDTH OF THE PATIENTS FACE FROM THE SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2561315 JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention