BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML

    MDR report key: 4142564 · Received September 30, 2014

    Report

    Report Number
    3005113652-2014-00516
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    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 EVENTS OF INFLAMMATION, "NODULE FORMATIONS", AND ABSCESS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING. UNDESIRABLE EFFECTS. THE PATIENT MUST BE INFORMED THAT THERE ARE POTENTIAL SIDE EFFECTS LINKED TO THIS PROCEDURE, WHICH CAN BE EITHER IMMEDIATE OR DELAYED. THESE INCLUDE BUT ARE NOT LIMITED TO: INFLAMMATORY REACTIONS (REDNESS, OEDEMA, ERYTHEMA, ETC.), WHICH CAN OCCUR SIMULTANEOUSLY WITH ITCHING OR PAIN ON PRESSURE, CAN APPEAR AFTER THE INJECTION. INDURATIONS OR NODULES AT THE INJECTION AREA. CASES OF NECROSES IN THE GLABELLAR REGION, ABSCESSES, GRANULOMA, AND IMMEDIATE OR DELAYED HYPERSENSITIVITY AFTER HYALURONIC ACID AND/OR LIDOCAINE INJECTIONS HAVE BEEN REPORTED. IT IS THEREFORE ADVISABLE TO TAKE THESE POTENTIAL RISKS INTO ACCOUNT.

    Description of Event or Problem · 1

    INJECTING NURSE REPORTED 1.5 MONTHS AFTER INJECTION WITH JUVEDERM VOLUMA WITH LIDOCAINE IN THE CHEEKS, THE PATIENT DEVELOPED "INFLAMMATION, LATE ONSET OF NODULE FORMATIONS UNDER THE SKIN AND ABSCESS ON THE LOWER LEFT CHEEK". THE PATIENT WAS TREATED WITH HYALURONIDASE BY THE INJECTING HEALTHCARE PROFESSIONAL. THE PATIENT WAS SUBSEQUENTLY REFERRED TO ANOTHER PHYSICIAN WHO RECOMMENDED ANTIBIOTICS AND INCISION/DRAINAGE OF THE ABSCESS; PATIENT DECLINED ANY ADDITIONAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608008 JUVEDERM VOLUMA WITH LIDOCAINE 1ML LMH ALLERGAN NA VB20A30282

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention COMPLAINT.| JUVEDERM ULTRA XC INJECTED IN THE LIPS WITH NO