BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA/24HV (VOLUME UNK)

    MDR report key: 3231406 · Received July 15, 2013

    Report

    Report Number
    3005113652-2013-00090
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO THE FDA ON 07/15/2013. ATTEMPTS TO FOLLOW UP WITH THE HEALTHCARE PROFESSIONAL HAVE NOT BEEN SUCCESSFUL, THEREFORE, DEVICE INFORMATION, SUCH AS THE LOT NUMBER, IS NOT AVAILABLE AT THIS TIME. DEVICE LABELING: UNDESIRABLE EFFECTS: THE PATIENTS MUST BE INFORMED THAT THEY ARE POTENTIAL SIDE EFFECTS ASSOCIATED WITH IMPLANTATION OF THIS PRODUCT, WHICH MAY OCCUR IMMEDIATELY OR MAY BE DELAYED. THESE INCLUDE, BUT ARE NOT LIMITED TO: INFLAMMATORY REACTIONS (REDNESS, OEDEMA, ERYTHEMA, ETC.) WHICH MAY BE ASSOCIATED WITH ITCHING OR PAIN ON PRESSURE OR BOTH, OCCURRING AFTER THE INJECTION. INDURATION OR NODULES AT THE INJECTION SITE. 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

    PHYSICIAN REPORTED 2.5 MONTHS AFTER INJECTION VIA CANNULA WITH JUVEDERM ULTRA IN THE LIPS, PATIENT DEVELOPED TWO NODULES ON THE LOWER LIP AND A NODULE ON THE TOP LIP. PHYSICIAN CONSIDERED THE POSSIBILITY THAT THE NODULES WERE GRANULOMAS, BUT NO BIOPSY HAS BEEN PERFORMED TO CONFIRM. PATIENT ALSO DEVELOPED SWELLING OF THE LIPS THAT WOULD RESOLVE FOR APPROXIMATELY THREE DAYS AND THEN REOCCUR FOR THREE DAYS. PATIENT WAS INITIALLY TREATED WITH PREDNISONE DURING WHICH THE SWELLING CONTINUED TO RESOLVE AND REOCCUR. PATIENT WAS THEN ADDITIONALLY TREATED WITH DOXYCYCLINE, AND HYALURONIDASE "JUST FOR THE SWELLING." SYMPTOMS ARE ONGOING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326708 JUVEDERM ULTRA/24HV (VOLUME UNK) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention