BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLBELLA WITH LIDOCAINE

    MDR report key: 8278266 · Received January 25, 2019

    Report

    Report Number
    3005113652-2019-00034
    Event Type
    Injury
    Date Received
    January 25, 2019
    Date of Event
    November 28, 2018
    Report Date
    January 25, 2019
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    UDI-DI
    10888628032460
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF "ERYTHEMATOUS TENDER NODULES" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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

    HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT IN AN UNSPECIFIED SITE WITH AN UNSPECIFIED AMOUNT OF JUVÉDERM VOLBELLA® XC. AT AN UNSPECIFIED TIME LATER, THE PATIENT EXPERIENCED ¿DELAYED NODULES.¿ NO OTHER INFORMATION WAS PROVIDED. THE INJECTOR LATER CONFIRMED INJECTING THE PATIENT IN THE VERMILLION, LIPS, MARIONETTE LINES, AND UPPER LIP LINE WITH .5 CC OF JUVÉDERM VOLBELLA® XC. THE SYMPTOMS FIRST APPEARED 8.5 MONTHS LATER WITH ¿ERYTHEMATOUS TENDER NODULES AT THE INJECTION SITES.¿ THE PATIENT WAS TREATED 2 DAYS LATER WITH INTRALESIONAL KENALOG, PREDNISONE, AND DOXYCYCLINE. THE PATIENT WAS THEN TREATED A WEEK LATER WITH ¿ILK¿ AND DOXYCYCLINE. THE PATIENT WAS THEN TREATED WITH HYLENEX AND DOXYCYCLINE 6 DAYS LATER, AGAIN 6 DAYS LATER, AND ONCE MORE 8 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71115 VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V15LA70358 10888628032460

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention