BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLBELLA WITH LIDOCAINE

    MDR report key: 8704250 · Received June 17, 2019

    Report

    Report Number
    3005113652-2019-00467
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    February 15, 2019
    Report Date
    August 19, 2019
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: DATE OF EVENT.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED SYMPTOMS HAVE RESOLVED.

    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 "INFLAMMATION" 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 ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED PATIENT WAS INJECTED WITH 1.6ML OF JUVÉDERM® VOLBELLA¿ WITH LIDOCAINE IN THE TEAR TROUGH. 8 MONTHS POST INJECTION, PATIENT PRESENTED "INFLAMMATION, NO PAIN, IN THE INJECTED SITES". TREATMENT: PREDNISONA. PATIENT "WAS BETTER" BUT ONE MONTH LATER THE INFLAMMATION APPEARED ONCE AGAIN. TREATMENT: HIALURONIDASA. SYMPTOMS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498752 VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V15LA70163

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention CORTICOIDE/ARNIK| CORTICOIDE/ARNIK