BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2 X 1ML

    MDR report key: 4534399 · Received February 19, 2015

    Report

    Report Number
    3005113652-2015-00047
    Event Type
    Injury
    Date Received
    February 19, 2015
    Date of Event
    December 29, 2014
    Report Date
    January 23, 2015
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 HARD NODULES, UPPER RESPIRATORY INFECTION, "HYPER IMMUNE REACTION," "ONE INJECTION DEEP INTO THE ZYGOMATIC ARCH PLACING DOWNWARD INTO THE LOWER ZYGOMATICA AND FEELS THAT WITH ONE INJECTION FACING DOWN, THERE ISN'T A TUNNEL OR CHANNEL FOR THE PRODUCT TO MIGRATE INFRA ORBITALLY," CELLULITIS, TENDERNESS, SWELLING, AND GRANULOMA FORMATION ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS INJECTED IN THE ZYGOMA WITH THREE SYRINGES OF JUVEDERM VOLUMA XC. HEALTHCARE PROFESSIONAL STATED APPROXIMATELY SIX MONTHS LATER, THE PATIENT PRESENTED WITH "BILATERAL HARD NODULES [AT THE] INFRA-ORBITAL REGION." THE DOCTOR STATED THEY "INJECTED 3 SYRINGES VIA CANNULA, ONE INJECTION DEEP INTO THE ZYGOMATIC ARCH PLACING DOWNWARD INTO THE LOWER ZYGOMATICA AND FEELS THAT WITH ONE INJECTION FACING DOWN, THERE ISN'T A TUNNEL OR CHANNEL FOR THE PRODUCT TO MIGRATE INFRA ORBITALLY." ADDITIONALLY, HEALTHCARE PROFESSIONAL INDICATED "PRIOR TO DEVELOPMENT OF NODULES, PATIENT HAD SEVERE URI, [AND WAS] TREATED WITH ZPAK, TAMIFLU, AND STEROID INJECTIONS" WHEN THE PATIENT VISITED THE EMERGENCY ROOM. THE PATIENT'S PRIMARY CARE PHYSICIAN PERFORMED A "SINUS XR" WHICH WAS NEGATIVE AND PRESCRIBED THE PATIENT LEVAQUIN. UPON FURTHER FOLLOW UP WITH THE HEALTHCARE PROFESSIONAL, IT WAS DISCOVERED THAT THE PATIENT WAS LATER PRESCRIBED TWO ROUNDS OF MEDROL DOSPAK AND PREDNISONE. THE NODULES HAVE SOFTENED AND THE PATIENT IS HAPPY. ADDITIONALLY, THE HEALTHCARE PROFESSIONAL STATED THAT THE PATIENT HAD A ''HYPER IMMUNE REACTION" AND THAT A "TEST" WAS PERFORMED AND WAS DISCOVERED THAT THE NODULES CONSISTED OF THE "HARDENED PRODUCT." ADDITIONAL INFORMATION FROM THE ALLERGIST WHO SAW THE PATIENT ALSO SHOWED THAT THE PATIENT HAS A HISTORY OF CHRONIC RHINITIS, WHICH MAY HAVE CONTRIBUTED TO THE SYMPTOMS. THE ALLERGIST OBSERVED BILATERAL CHEEK EDEMA, ALONG WITH TENDERNESS; THE ALLERGIST ALSO SUSPECTED THE PATIENT MAY HAVE CELLULITIS OR A "GRANULOMA FORMATION." HEALTHCARE PROFESSIONAL PLANS TO CONTINUE PATIENT ON PREDNISONE AND MONITOR CLOSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120092 JUVEDERM VOLUMA XC 27G 2 X 1ML IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) VB20A40107

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention