BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC/LIDO (VOLUME UNKNOWN)

    MDR report key: 20764237 · Received November 22, 2024

    Report

    Report Number
    3005113652-2024-00771
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    November 14, 2024
    Report Date
    November 22, 2024
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 HAS BEEN DISCARDED. 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

    A HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 1 CC OF JUVÉDERM® ULTRA XC IN THE MARIONETTE LINES. ONE MONTH LATER, PATIENT EXPERIENCED GRANULOMA WITH HARD LUMPS 10-20 PER SIDE. PATIENT WAS TREATED WITH AKX (DOXY 100 MG), & MEDKOL PACK. SYMPTOMS HAVE NOT FULLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2601445 JUVEDERM ULTRA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH PRINGY NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention