BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLBELLA XC 2 X 1ML 32G

    MDR report key: 8663120 · Received June 3, 2019

    Report

    Report Number
    3005113652-2019-00418
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    February 22, 2019
    Report Date
    June 3, 2019
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER 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 · 1

    HEALTHCARE PROFESSIONAL REPORTED TO HAVE INJECTED A PATIENT IN THE LIPS AND PERIORAL AREA WITH JUVÉDERM® VOLBELLA® XC. THE PATIENT WAS TAKING A LIVER CLEANSE SUPPLEMENT CONCOMITANTLY. ABOUT A MONTH AND A HALF LATER, THE PATIENT EXPERIENCED ¿GRANULOMAS¿ AT THE INJECTION SITE. A BIOPSY CONFIRMED THE EVENT. ON THE SATE OF ONSET, THE PATIENT BEGAN TREATMENT WITH DOXYCYCLINE, WHICH WENT ON FOR 14 DAYS. THE PATIENT WAS ADDITIONALLY TREATED ON THIS DAY WITH TMC 0.1% AND I&D AND DRAINAGE WERE ATTEMPTED. 2 WEEKS LATER, THE PATIENT WAS TREATED WITH AN ILK INJECTION AND PREDNISONE TAPER. 4 DAYS LATER, THE PATIENT WAS TREATED WITH HYLENEX®. PREDNISONE TAPER WAS CONTINUED ON THIS DAY. 3 DAYS LATER, THE PATIENT CONTINUED PREDNISONE TREATMENT. THE SYMPTOMS ARE ¿RESOLVING SLOWLY¿. THE PATIENT IS IMPROVING CLINICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457620 JUVEDERM VOLBELLA XC 2 X 1ML 32G IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V15LA70798

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention LIVER CLENSE SUPPLEMENT