BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLLURE XC 2X1 ML

    MDR report key: 11567620 · Received March 25, 2021

    Report

    Report Number
    3005113652-2021-00182
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    January 8, 2021
    Report Date
    March 24, 2021
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    10888628034471
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENTS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. THE FILLER WAS INJECTED INTO THE PATIENT AND IS NOT ACCESSIBLE FOR RETURN. THE SYRINGE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED INJECTING A PATIENT IN THE TEAR TROUGHS WITH 1.5 ML OF JUVÉDERM VOLLURE¿ XC. TWO MONTHS LATER, THE PATIENT HAD THEIR FIRST MODERNA COVID-19 VACCINE AND EXPERIENCED ¿SWELLING¿ AT THE INJECTION SITE. THE INJECTOR NOTED ¿FOREIGN BODY GRANULOMA.¿ BIOPSY WAS NOT PROVIDED. THE NEXT DAY, THE PATIENT WAS TREATED WITH LISINOPRIL PO Q DAY (5MG). THE PATIENT WAS ALSO TREATED WITH HYLENEX. THE PATIENT RECEIVED THEIR SECOND MODERNA COVID-19 VACCINE 18 DAYS LATER. TWO WEEKS LATER, THE PATIENT WAS TREATED WITH ADDITIONAL 1 ML OF HYLENEX AND A MEDROL DOSEPAK. TWELVE DAYS LATER, THE PATIENT RECEIVED INTRALESIONAL TRIAMCINOLONE 4 MG/CC (0.3 ML). THE EVENT RESOLVED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467230 JUVEDERM VOLLURE XC 2X1 ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V17LB00435 10888628034471

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention