BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC/LIDO (VOLUME UNK)

    MDR report key: 4435844 · Received January 16, 2015

    Report

    Report Number
    3005113652-2014-00787
    Event Type
    Injury
    Date Received
    January 16, 2015
    Date of Event
    October 28, 2014
    Report Date
    December 22, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) #: N/A. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ALLERGAN IS UNABLE TO CONFIRM WITH THE HEALTHCARE PROFESSIONAL, THEREFORE, ADDITIONAL EVENT, PRODUCT, OR PATIENT DETAILS ARE NOT ATTAINABLE. THE EVENTS OF SENSE OF BURNING SKIN AT THE INJECTION SITES, NUMBNESS, "FULLNESS OF RIGHT EAR," HEARING LOSS IN THE RIGHT EAR, AND WATERY EYES ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING PROBABLE CAUSES FOR THESE EVENTS. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF PAIN, INFLAMMATION, BLURRED VISION, AND HEARING LOSS AS FOLLOWS: POST MARKET SURVEILLANCE: "JUVEDERM VOLUMA WITHOUT LIDOCAINE HAS BEEN MARKETED OUTSIDE THE US SINCE 2005, AND JUVEDERM VOLUMA WITH LIDOCAINE HAS BEEN MARKETED OUTSIDE THE US SINCE 2009". "AS OF 12/31/2012, THE FOLLOWING AES WERE RECEIVED FROM POST-MARKET SURVEILLANCE FOR JUVEDERM VOLUMA WITH AND WITHOUT LIDOCAINE WITH A FREQUENCY GREATER 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 AERS 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

    PATIENT'S HUSBAND REPORTED IMMEDIATELY AFTER INJECTION WITH TWO SYRINGES OF "JUVEDERM VOLUMA XC" IN "SOME AREA OF CHEEK BELOW EYE LEVEL AND SOME AREA ABOVE EYE LEVEL BETWEEN EAR AND EYE CLOSE TO THE EAR AND CLOSE TO THE EYE," THE PATIENT EXPERIENCED A SENSE OF BURNING OF SKIN AT THE INJECTION SITES, NUMBNESS AT THE INJECTED AREA, THEY FELT FULLNESS OF RIGHT EAR, WATERY EYES, AND BLURRY VISION. AROUND ONE MONTH LATER THE PATIENT EXPERIENCED SUBSTANTIAL HEARING LOSS IN THE RIGHT EAR. AN ENT PRESCRIBED ORAL KEFLEX FOR THE PATIENT. SYMPTOMS ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40800 JUVEDERM VOLUMA XC/LIDO (VOLUME UNK) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention BENICAR