BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN)

    MDR report key: 19425546 · Received May 30, 2024

    Report

    Report Number
    3005113652-2024-00360
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    May 8, 2024
    Report Date
    May 30, 2024
    Manufacturer
    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 D.6A.: BETWEEN SEP/2021 AND OCT/2022. CLARIFICATION TO E.1. FACILITY NAME: THE FOURTH MEDICAL CENTER OF CHINESE PEOPLE'S LIBERATION ARMY GENERAL HOSPITAL 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: FU, HUIJUAN, ET AL. ¿EFFICACY OF SUPERSELECTIVE INTRA-ARTERIAL RECANALIZATION OF EMBOLIZED ARTERIES RESULTING FROM FACIAL HYALURONIC ACID INJECTION.¿ AESTHETIC PLASTIC SURGERY, HTTPS://DOI.ORG/10.1007/S00266-024-04004-2. 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.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "EFFICACY OF SUPERSELECTIVE INTRA-ARTERIAL RECANALIZATION OF EMBOLIZED ARTERIES RESULTING FROM FACIAL HYALURONIC ACID INJECTION", HEALTHCARE PROFESSIONAL NOTED A PATIENT WAS INJECTED WITH 1ML OF AN UNSPECIFIED JUVEDERM INTO THE NASOLABIAL GROOVES, 0.6MLS INTO THE RIGHT SIDE AND 0.4MLS INTO THE LEFT SIDE. FOLLOWING INJECTION, PATIENT WAS SUFFERING FROM NUMBNESS AND PAIN AND WAD ADMITTED TO THE HOSPITAL 2 DAYS LATER. LIVEDO RETICULARIS WAS OBSERVED IN THE RIGHT NASOLABIAL GROOVE AND UPPER LIP. PATIENT UNDERWENT INTRA-ARTERIAL RECANALIZATION WITH GUIDANCE OF AN ANGIOGRAPHY MACHINE WITH 60MG OF PAPAVERINE AND 3000 UNITS OF HYALURONIDASE BEING INJECTED INTO THE TARGET BLOOD VESSELS. PATIENT WAS ALSO GIVEN MANNITOL, DEXAMETHASONE SODIUM PHOSPHATE, AND MECOBALAMIN INTRAVENOUSLY, AFTER THE INJECTION, IMPROVED BLOOD PERFUSION AND INCREASED BLOOD FLOW VELOCITY WERE NOTICED. ONE DAY LATER, THE PAIN AND NUMBNESS WERE SIGNIFICANTLY RELIEVED AND THE LIVEDO RETICULARIS WAS SIGNIFICANTLY RELIEVED 3 DAYS LATER. MICROPLASMA RADIO FREQUENCY AND CONCENTRATED GROWTH FACTORS WERE USED TO PROMOTE TISSUE REPAIRS AND REGENERATION 8 DAYS LATER. PATIENT WAS DISCHARGED 15 DAYS AFTER ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258824 JUVEDERM (VOLUME/CONCENTRATION/ADDITIVE UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Hospitalization| R