BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN)

    MDR report key: 20466025 · Received October 16, 2024

    Report

    Report Number
    3005113652-2024-00638
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    May 8, 2024
    Report Date
    October 16, 2024
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Product Problem
    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. 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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. ARTICLE : FU, H., FU, Q., YU, Y., YANG, Y., ZHENG, C., XU, X., ZHOU, G., DING, H., WU, Q., & CHEN, M. (2024). EFFICACY OF SUPERSELECTIVE INTRA-ARTERIAL RECANALIZATION OF EMBOLIZED ARTERIES RESULTING FROM FACIAL HYALURONIC ACID INJECTION. AESTHETIC PLASTIC SURGERY, 48(18), 3561¿3567. HTTPS://DOI.ORG/10.1007/S00266-024-04004-2

    Description of Event or Problem · 0

    IN THE ARTICLE ¿EFFICACY OF SUPERSELECTIVE INTRA-ARTERIAL RECANALIZATION OF EMBOLIZED ARTERIES RESULTING FROM FACIAL HYALURONIC ACID INJECTION,¿ A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS INJECTED WITH AN UNSPECIFIED JUVÉDERM® OF 0.6 ML INTO RIGHT NASOLABIAL GROOVE AND 0.4 ML INTO LEFT SIDE. TWO DAYS LATER, THE PATIENT EXPERIENCED PAIN AND NUMBNESS AT THE INJECTION SITE, WITH "LIVEDO RETICULARIS¿ WAS OBSERVED IN THE RIGHT NASOLABIAL GROOVE AND UPPER LIP. SUPERSELECTIVE INTRA-ARTERIAL RECANALIZATION THERAPY WAS PERFORMED, AND THE EMBOLIZED FACIAL ARTERY AND ITS BRANCHES WITH LOW BLOOD PERFUSION COULD BE CLEARLY OBSERVED BY DSA (DIGITAL SUBTRACTION ANGIOGRAPHY). FOLLOWING TREATMENT WITH 60 MG PAPAVERINE AND 3000 UNITS HYALURONIDASE, IMPROVED BLOOD PERFUSION AND INCREASED BLOOD FLOW VELOCITY OF FACIAL ARTERY AND ITS BRANCHES WERE OBSERVED VIA DSA. THE PATIENT EXPERIENCED SIGNIFICANT RELIEF FROM PAIN AND NUMBNESS ONE DAY AFTER THE PROCEDURE, AND THE LIVEDO RETICULARIS IMPROVED NOTICEABLY WITHIN 3 DAYS. MICROPLASMA RADIO FREQUENCY AND CONCENTRATED GROWTH FACTORS WERE APPLIED 8 DAYS AFTER THE OPERATION TO PROMOTE TISSUE REPAIR AND REGENERATION . THE PATIENT WAS SATISFACTORILY DISCHARGED 15 DAYS AFTER THE PROCEDURE WITH SYMPTOMS FULLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248719 JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention