BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLBELLA WITH LIDOCAINE

    MDR report key: 8621358 · Received May 17, 2019

    Report

    Report Number
    3005113652-2019-00358
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    March 20, 2019
    Report Date
    May 17, 2019
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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 INJECTING A PATIENT IN THE UPPER AND LOWER LIPS WITH .55 CC OF JUVÉDERM VOLBELLA® XC. ABOUT 3 MONTHS LATER, THE PATIENT EXPERIENCED ¿MULTIPLE FIRM NODULES PALPABLE IN BOTH UPPER AND LOWER LIP, [AND] MILD EDEMA.¿ THAT SAME DAY, THE PATIENT WAS TREATED WITH PREDNISONE. THE PATIENT THEN HAD A DENTAL CLEANING 5 DAYS LATER. THE PATIENT WAS TREATED WITH ZITHROMAX DOSEPAK AND A MEDROL STEROID DOSEPAK A WEEK AND A HALF LATER. THE SYMPTOMS FULLY RESOLVED 5 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413553 VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) V15LA80465

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention