BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN)

    MDR report key: 9457878 · Received December 12, 2019

    Report

    Report Number
    3005113652-2019-00858
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    August 20, 2013
    Report Date
    December 12, 2019
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER HAS DECLINED TO PROVIDE ALLERGAN FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS. 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 · 1

    HEALTHCARE PROFESSIONAL REPORTS 2 ML JUVÉDERM¿ VOLUMA¿ WITH LIDOCAINE INJECTION TO CHEEKS, UPPER NLF AND MARIONETTE. PATIENT EXPERIENCED DELAYED ONSET NODULES TO L MARIONETTE 11 MONTHS LATER. THE FOLLOWING MONTH, SYMPTOM APPEARED AT R NLF AND R CHEEK. HA 75 U/ML X 0.3ML TO R CHEEK/NLF PROVIDED AS TREATMENT ONE MONTH LATER. SWELLING CONTINUED. 5 DAYS AFTER TREATMENT, EVENT MUCH IMPROVED. ONE WEEK LATER, ILK 13MG/ML X 0.5ML APPLIED INTO 3 SITES. EVENT RESOLVED THE FOLLOWING MONTH. POTENTIAL TRIGGER NOTED AS GUM IRRITATION WITH INVISALIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253983 JUVEDERM VOLUMA XC/LIDO (VOLUME UNKNOWN) IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention