BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2 X 1ML

    MDR report key: 4142575 · Received September 30, 2014

    Report

    Report Number
    3005113652-2014-00487
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF "SWELLING", "LOCK JAW-TMJ SYNDROME", "INFLAMMATION" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE HISTORY RECORD SUMMARY: THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MANUFACTURING STEPS AND ALL THE PHYSIOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING. DEVICE LABELING: TREATMENT SITE REACTIONS CONSIST MAINLY OF SHORT-TERM INFLAMMATORY SYMPTOMS AND GENERALLY RESOLVE WITHIN 2 TO 4 WEEKS. OTHER SAFETY DATA POST-MARKET SURVEILLANCE JUVEDERM VOLUMA WITHOUT LIDOCAINE HAS BEEN MARKETED OUTSIDE THE US SINCE 2004, AND JUVEDERM VOLUMA WITH LIDOCAINE HAS BEEN MARKETED OUTSIDE THE US SINCE 2009. AS OF DECEMBER 31, 2012, THE FOLLOWING AES WERE RECEIVED FROM POST-MARKET SURVEILLANCE FOR JUVEDERM VOLUMA WITH AND WITHOUT LIDOCAINE WITH A FREQUENCY (B)(4) 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 THAT 4 DAYS AFTER INJECTION IN THE CHEEKS WITH JUVEDERM VOLUMA XC (3 SYRINGES WITH 3 DIFFERENT LOT NUMBERS), THE PATIENT EXPERIENCED SWELLING IN THE "CHEEKS, TEMPLES AND JAWLINE," AS WELL AS "LOCK JAW-TMJ SYNDROME" BILATERALLY IN THE JAW. HEALTHCARE PROFESSIONAL STATED THAT THE SWELLING WAS "LIKELY CHRONIC AND LATE INFLAMMATION DUE TO IRRITATION OF BONE (OSTEITIS) DUE TO INJECTION AND POSITION OF VOLUMA." ON THE DATE OF SYMPTOM OCCURRENCE, HEALTHCARE PROFESSIONAL ADVISED THE PATIENT TO TAKE MOTRIN (800 TID), AND APPLY ICE AND HEAT. FIVE DAYS LATER, PATIENT WAS TREATED WITH A MEDROL DOSEPAK AND KEFLEX. TWO DAYS LATER, PATIENT WAS PRESCRIBED PREDNISONE WHICH WAS REPORTED AS EFFECTIVE. APPROXIMATELY A WEEK AND A HALF LATER, PATIENT WAS PRESCRIBED BACTRIM AND AUGMENTIN, WHICH WERE NOT EFFECTIVE. APPROXIMATELY TWO WEEKS LATER, PATIENT WAS TREATED WITH ADDITIONAL PREDNISONE WHICH HAS BEEN EFFECTIVE THUS FAR, AS SYMPTOMS ARE "IMPROVING BUT NOT RESOLVED TO DATE." INJECTOR REPORTED THAT THE PATIENT DID NOT REPORT IT PRIOR TO THE INJECTION BUT LATER IT EMERGED THAT THEY HAD BEEN PREVIOUSLY DIAGNOSED WITH RHEUMATOID ARTHRITIS AND SAPHO SYNDROME. THE PATIENT'S SYMPTOMS WERE CONSIDERED PRODUCT-RELATED BY THE INJECTOR. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2014-00488 ((B)(4)) AND MDR ID # 3005113652-2014-00489 ((B)(4)). THIS IS THE THIRD MDR SUBMITTED FOR THE THIRD SUSPECT PRODUCT, JUVEDERM VOLUMA XC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608019 JUVEDERM VOLUMA XC 27G 2 X 1ML LMH ALLERGAN NA VB20A40178

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention VB20A40127)| JUVEDERM VOLUMA XC (LOT NUMBERS: VB20A40126 AND