BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2 X 1ML

    MDR report key: 3932020 · Received June 20, 2014

    Report

    Report Number
    3005113652-2014-00272
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 23, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENTS OF "RED BURNING SENSATION, SWELLING, RASH AND FLAKY SKIN", PRODUCT HAS "FALLEN", CAN "FEEL AND HEAR IT SQUISHING AROUND", CHEEKS FEEL "FULL" AND PAIN ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING: ADVERSE EVENTS. CLINICAL EVALUATION OF JUVEDERM VOLUMA XC TREATMENT SITE RESPONSES REPORTED BY LESS THAN OR EQUAL TO 5 PERCENT OF SUBJECTS INCLUDED ACHE, ACNE, BULGE, BUMPS, CHEEK LARGER UPON WAKING UP, DRY PATCH, FINE WRINKLES, INJECTION/NEEDLE MARKS, NUMBNESS, PIGMENTATION FROM TREATMENT, PUFFINESS, RASH, SCRATCH NEAR INJECTION POINT, SORENESS, TIGHTNESS, AND YELLOWNESS. DEVICE AND INJECTION RELATED ADVERSE EVENTS OCCURRING IN LESS THAN OR EQUALLY 1 PERCENT OF SUBJECTS INCLUDED INJECTION 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). TWO SUBJECTS (0.7 PERCENT; 2/270) REPORTED 3 SERIOUS ADVERSE EVENTS (SAES) THAT WERE CONSIDERED TO BE RELATED TO THE DEVICE. APPROXIMATELY 6 MONTHS AFTER TREATMENT, AFTER BEING SCRATCHED NEAR THE TREATED AREA BY A TREE BRANCH, ONE SUBJECT EXPERIENCED INFLAMMATION UNDER THE LEFT EYE. THE SUBJECT ALSO EXPERIENCED NODULARITY IN THE RIGHT CHEEK APPROXIMATELY 7 MONTHS AFTER TREATMENT, THE SECOND SUBJECT EXPERIENCED LUMPS IN THE CHEEKS APPROXIMATELY 7 MONTHS AFTER TREATMENT. A COUPLE OF DAYS BEFORE THE ONSET, THE SUBJECT EXPERIENCED MYOFASCIAL PAIN AND BODY ACHES. TREATMENT OF THE SAES INCLUDED TOPICAL STEROIDS, ORAL ANTIBIOTICS, INTRALESIONAL STEROIDS, ANTI-INFLAMMATORY MEDICATION, AND HYALURONIDASE. ALL EVENTS RESOLVED. OTHER SAFETY DATA. 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 (B)(4) 2012, THE FOLLOWING AES WERE RECEIVED FROM POST-MARKET SURVEILLANCE FOR JUVEDERM VOLUMA WITH AND 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

    PT REPORTED APPROXIMATELY 1 WEEK AFTER INJECTION WITH JUVEDERM VOLUMA IN THE "TOP OF THE CHEEK BONE" AND RESTYLANE IN THE LIPS, THEY DEVELOPED REDNESS, A "BURNING SENSATION," SWELLING, A RASH, AND "FLAKY SKIN" ON THE LIPS, CHIN, AND AREA AROUND THE MOUTH. THE PT COMMENTED THAT IT FEELS LIKE THE PRODUCT HAS "FALLEN" FROM THE AREA OF INJECTION TO THE "NOSE AND PARENTHESES" AREA. ADDITIONALLY, THE PT INDICATED THEY CAN "FEEL (THE PRODUCT) AND HEAR IT SQUISHING AROUND" AND THEIR CHEEKS FEEL "FULL." TREATMENT OF SYMPTOMS INCLUDED AMOXICILLIN, PREDNISONE, VALTREX, AND BACTRIM. THE PT BELIEVES THE HEALTHCARE PROFESSIONAL "INJECTED THE PRODUCT INCORRECTLY." FOLLOW UP WITH THE TREATING HEALTHCARE PROFESSIONAL PROVIDED CLARIFICATION OF THE PRECEDING PT REPORT: APPROXIMATELY 2.5 AFTER INJECTION WITH 2 SYRINGES OF JUVEDERM VOLUMA XC IN THE CHEEKS, NASOLABIAL FOLDS, AND "MALARS" AND CONCOMITANT INJECTION OF 1 SYRINGE OF JUVEDERM ULTRA PLUS XC IN THE LIPS, THE PT RETURNED TO THE INJECTING HEALTHCARE PROFESSIONAL'S OFFICE INDICATING THEY WERE "DISSATISFIED" WITH THE SYMMETRY OF THE LIPS. THE PT WAS INJECTED WITH 1 SYRINGE OF JUVEDERM ULTRA XC IN THE LIPS TO CORRECT FOR THE UNSATISFACTORY RESULT. APPROXIMATELY ONE WEEK AFTER INJECTION WITH JUVEDERM ULTRA XC THE PT DEVELOPED A "REACTION" "ALL AROUND (THE) MOUTH, NASOLABIAL FOLDS, DOWN AND UNDER (THE) CHIN, AND SIDE OF NOSE." THE PT WAS TREATED WITH VALTREX, BACTROBAN, BENADRYL AND PERCOCET FOR PAIN. THE TREATING HEALTHCARE PROFESSIONAL STATED THEY BELIEVED THAT THE PT HAS SEEN OTHER HEALTHCARE PROFESSIONALS SINCE ONSET, AS WELL, ALTHOUGH THEY DID NOT KNOW THE DETAILS OTHER THAN THERE WAS NO DECISIVE CONCLUSION ABOUT ETIOLOGY OF SYMPTOMS. THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID # 3005113652-2014-00304 (ALLERGAN COMPLAINT # (B)(4)) AND MDR ID# 3005113652-2014-00305 (ALLERGAN COMPLAINT # (B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVEDERM VOLUMA XC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362439 JUVEDERM VOLUMA XC 27G 2 X 1ML LMH ALLERGAN NA VB20A30186

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention JUVEDERM ULTRAPLUS XC| "COMPOUND NUMBING CREAM"| ARNICA| BOTOX