BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)

    MDR report key: 21001870 · Received December 23, 2024

    Report

    Report Number
    3005113652-2024-00837
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    December 9, 2024
    Report Date
    January 28, 2025
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL (HCP) REPORTED INJECTING A PATIENT IN THE CHIN AND MIDFACE WITH 1/3 SYRINGE OF JUVÉDERM VOLUMA® XC. THAT SAME DAY, THE PATIENT EXPERIENCED A ¿VO AT THE INJECTION AREAS, PATIENT NOW NOTICING BLISTERING ON LIP.¿ THE PATIENT WAS IMMEDIATELY TREATED WITH HYLENEX®LOCAL IN FILTRATION AND WAS GIVEN THE SAME TREATMENT THE TWO DAYS FOLLOWING. THREE DAYS LATER, THE PATIENT WAS TREATED WITH HYPERBARIC CHAMBER (ONE TREATMENT). THE FOLLOWING DAY THE PATIENT WAS ALSO TREATED WITH EOZ DEVICE (LOCAL FOR LWK). THE HCP ADDITIONALLY REPORTED ¿ON GOING DISCOLORATION BELOW LOWER LIP DISCOLORATION CHIN ALSO NO PAIN ON OPEN SPOTS.¿ SYMPTOMS ARE ONGOING.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REPORTED SYMPTOM RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79701 JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY NI

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention