BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2 X 1ML

    MDR report key: 3932021 · Received June 20, 2014

    Report

    Report Number
    3005113652-2014-00265
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENTS OF "INFLAMMATION, URTICARIA, AND ERYTHEMA" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING: WARNINGS.: TREATMENT SITE REACTIONS CONSIST MAINLY OF SHORT-TERM INFLAMMATORY SYMPTOMS AND GENERAL RESOLVE WITHIN 2 TO 4 WEEKS. REFER TO THE ADVERSE EVENTS SECTION FOR DETAILS. ADVERSE EVENTS: CLINICAL EVALUATION OF JUVEDERM VOLUMA XC DEVICE- AND INJECTION RELATED ADVERSE EVENTS OCCURRING IN LESS THAN OR EQUAL TO 1 PERCENT OF SUBJECTS INCLUDED SITE HYPERTROPHY (0.7 PERCENT), NODULE (0.7 PERCENT), INFLAMMATION (0.4 PERCENT), INJECTION SITE ANESTHESIA (0.4 PERCENT), INJECTION SITE DRYNESS (0.4 PERCENT), INJECTION SITE EROSION (0.4 PERCENT), MASS (0.4 PERCENT), CONTUSION (0.4 PERCENT) AND SYNCOPE (0.4 PERCENT). OTHER SAFETY DATA. POST-MARKET SURVEILLANCE. JUVEDERM VOLUMA WITHOUT LIDOCAINE HAS BEEN MARKETED OUTSIDE THE USE SINCE 2005, AND JUVEDERM VOLUMA WITH LIDOCAINE HAS BEEN MARKETED OUTSIDE THE US SINCE 2009. AS OF (B)(4) 2012, THE FOLLOWING AES WERE RECEIVED FROM POST-MARKET SURVEILLANCE FOR JUVEDERM VOLUMA WITH AN WITHOUT LIDOCAINE WITH A FREQUENCY GREATER THAN OR EQUAL TO 5 AND WERE NOT OBSERVED IN THE CLINICAL STUDY; THIS INCLUDES REPORTS RECEIVED GLOBALLY FROM ALL SOURCES INCLUDING SCIENTIFIC JOURNALS AND VOLUNTARY REPORTS. ALL AES OBTAINED THROUGH POST-MARKET SURVEILLANCE ARE LISTED IN ORDER OF NUMBER OF REPORTS RECEIVED: INFLAMMATORY REACTION, LACK OF CORRECTION, INFECTION, MIGRATION, GRANULOMA, ALLERGIC REACTION, ABSCESS, NECROSIS, NUMBNESS, AND VISION ABNORMALITIES. REPORTED TREATMENTS INCLUDE: ANTIBIOTICS, STEROIDS, HYALURONIDASE, ANTI-INFLAMMATORIES, ANTI-HISTAMINES, ASPIRATION, RADIO FREQUENCY THERAPY, LASER TREATMENT, ICE, MASSAGE, WARM COMPRESS, ANALGESICS, ANTI-VIRAL, ULTRASOUND, EXCISION, DRAINAGE, AND SURGERY.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED 1 DAY AFTER INJECTION WITH JUVEDERM VOLUMA XC IN THE UPPER BILATERAL CHEEKS THE PT DEVELOPED A "HOT AREA ON THE FACE" REDNESS, AND HIVES. THE PT WAS TREATED WITH A MEDROL DOSEPAK, "OTC ANTIHISTAMINES", AND KEFLEX THE SAME DAY AS SYMPTOM ONSET. PT'S SYMPTOMS RESOLVED 24 HOURS AFTER TREATMENT WAS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362404 JUVEDERM VOLUMA XC 27G 2 X 1ML LMH ALLERGAN NA VB20A40024

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention