BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINVIVE BY JUVEDERM

    MDR report key: 24960004 · Received April 22, 2026

    Report

    Report Number
    3005113652-2026-00393
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 26, 2026
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A PATIENT UNDERWENT A "PICO SPOT, PICO TONING, PICO FRACTIONAL, POTENZA AND LDM" AND WAS THEN INJECTED WITH SKINVIVE BY JUVEDERM INTO THE CHEEK AND EXPERIENCED A MICROVESICULAR EMBOLISM, WITH SYMPTOMS APPEARING 5 DAYS AFTER INJECTION IN THE CHEEK. PATIENT WAS TREATED WITH HYALURONIDASE. EVENT ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545564 SKINVIVE BY JUVEDERM IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY NI

    Patients

    Seq Age Sex Outcome Treatment
    1