BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION UNK)

    MDR report key: 4522888 · Received February 12, 2015

    Report

    Report Number
    3005113652-2015-00023
    Event Type
    Injury
    Date Received
    February 12, 2015
    Date of Event
    January 9, 2015
    Report Date
    January 15, 2015
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) #: NOT APPLICABLE. 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 BRUISING LUMP AND "NO CHANGE TO THE WRINKLES" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. POST-MARKET SURVEILLANCE: "THE FOLLOWING ADVERSE EVENTS WERE RECEIVED FROM POSTMARKET SURVEILLANCE FOR JUVEDERM ULTRA (WITHOUT LIDOCAINE), WHICH WERE NOT OBSERVED IN THE CLINICAL TRIALS; THIS INCLUDES REPORTS RECEIVED GLOBALLY FROM ALL SOURCES INCLUDING SCIENTIFIC JOURNALS AND VOLUNTARY REPORTS. ADVERSE EVENTS WITH A FREQUENCY OF 5 OR MORE EVENTS ARE LISTED IN ORDER OF PREVALENCE: INFLAMMATION AT THE INJECTION SITE, ALLERGIC REACTION, BLISTER, INFECTION AT THE INJECTOR SITE, SKIN RASH, BLEEDING AT THE INJECTION SITE, NECROSIS AT THE INJECTION SITE, ABSCESS AT THE INJECTION SITE, AND HEADACHE." "INFLAMMATION AT THE INJECTION SITE, MOSTLY A NONSERIOUS EVENT, HAS BEEN REPORTED IN ASSOCIATION WITH EDEMA, ERYTHEMA, ECCHYMOSIS, PRURITUS, INDURATION, PAIN, NODULE, ABSCESS, AND INFECTION. TIME TO ONSET RANGED FROM 1 DAY TO 4 MONTHS POST JUVEDERM ULTRA PLUS INJECTION, AND OUTCOME RANGED FROM RESOLVED TO ONGOING AT LAST CONTACT. INTERVENTIONS PRESCRIBED BY THE PHYSICIANS INCLUDED TOPICAL STEROIDAL CREAM, ORAL STEROIDS, AND ANTIBIOTICS. ADDITIONAL TREATMENT NOTED WAS A NEEDLE ASPIRATION FOR DRAINAGE OF AN ABSCESS." "SERIOUS ADVERSE EVENTS HAVE INFREQUENTLY BEEN REPORTED FOR JUVEDERM ULTRA PLUS (REPORTED WITH A FREQUENCY OF 5 OR MORE). THE MOST COMMONLY REPORTED SERIOUS ADVERSE EVENTS WERE EDEMA, ERYTHEMA, ECCHYMOSIS, AND PAIN." "THE ONSET OF ECCHYMOSIS GENERALLY VARIED FROM IMMEDIATE TO 1 DAY POST-INJECTION. THE TREATMENT PRESCRIBED INCLUDED NSAIDS, ANTIHISTAMINES, ANTIBIOTICS, STEROIDS, AND HYALURONIDASE. IN MOST CASES ECCHYMOSIS RESOLVED WITHIN A FEW DAYS TO 6 WEEKS." "ADDITIONALLY THERE HAVE BEEN REPORTS OF NODULES, INFECTION, AND INFLAMMATION." "THE ONSET OF NODULES GENERALLY VARIED FROM IMMEDIATE TO 2 MONTHS POST-INJECTION. THE TREATMENT PRESCRIBED INCLUDED NSAID'S, ANTIBIOTICS, STEROIDS, AND HYALURONIDASE. IN MOST CASES NODULES RESOLVED WITHIN 1 MONTH." "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 DECEMBER 31, 2012, THE FOLLOWING AES WERE RECEIVED FROM POST-MARKET SURVEILLANCE FOR JUVEDERM VOLUMA WITH AND WITHOUT LIDOCAINE WITH A FREQUENCY GREATER THAN 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, EXCISIONS, DRAINAGE, AND SURGERY."

    Description of Event or Problem · 1

    PATIENT REPORTED THAT ONE DAY AFTER INJECTION IN THE NASOLABIAL FOLDS AND "LIP AREA" WITH "JUVEDERM," THE PATIENT EXPERIENCED BRUISING ON BOTH SIDES OF THE FACE, A LUMP ON THE RIGHT SIDE AND "NO CHANGE TO THE WRINKLES THEMSELVES ON EITHER SIDE" AT THE INJECTION SITES. THE PATIENT WAS GIVEN AN ICE PACK, A "TOPICAL STEROID" AND ADVISED TO TAKE ADVIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104735 JUVEDERM (VOLUME/CONCENTRATION UNK) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention GENERIC THYROID MEDICATION