BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN)

    MDR report key: 22968184 · Received September 4, 2025

    Report

    Report Number
    3005113652-2025-00785
    Event Type
    Injury
    Date Received
    September 4, 2025
    Report Date
    September 4, 2025
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    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.

    Description of Event or Problem · 0

    ATTORNEY REPORTED THAT A PATIENT WAS INJECTED WITH JUVÉDERM VISTA ULTRA AND JUVÉDERM VISTA ULTRA PLUS. THE PATIENT SUFFERED ¿OCULOMOTOR PALSY DUE TO VASCULAR OCCLUSION." EVENT IS ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6); (EMDR-101745). THIS EMDR IS BEING SUBMITTED FOR THE SUSPECT PRODUCT, JUVÉDERM VISTA ULTRA PLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2412692 JUVEDERM ULTRA PLUS/30HV (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown