BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)

    MDR report key: 12108313 · Received July 2, 2021

    Report

    Report Number
    3005113652-2021-03034
    Event Type
    Injury
    Date Received
    July 2, 2021
    Date of Event
    September 15, 2020
    Report Date
    July 2, 2021
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. CLARIFICATION: THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    PATIENT REPORTED BEING INJECTED IN THE JAWLINE JW 4, JW 5 AND C2 WITH JUVÉDERM® VOLUX¿ AND JUVÉDERM® VOLUMA¿. APPROXIMATELY A YEAR LATER, PATIENT DEVELOPED A PAINFUL SWELLING DUE TO AN INFECTION AND WAS TREATED WITH ORAL STEROIDS (PREDNISOLON 50 MG OVER SEVERAL DAYS). EVENTS RESOLVED. SIX MONTHS LATER, PATIENT HAD A COVID-19 (ASTRA ZENECA) VACCINATION. ONE DAY AFTER VACCINATION, THE PAINFUL SWELLING RE-APPEARED AT THE INJECTION SITE. PAINFUL SWELLING IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005824 JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention JUVÉDERM® VOLUX¿