BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION UNKNOWN)

    MDR report key: 4407157 · Received January 8, 2015

    Report

    Report Number
    3005113652-2014-00770
    Event Type
    Injury
    Date Received
    January 8, 2015
    Date of Event
    December 9, 2014
    Report Date
    December 15, 2014
    Manufacturer
    ALLEGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) #: NOT APPLICABLE. FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE EVENT OF SWELLING IN THE FACIAL AREA IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF EDEMA AS FOLLOWS: ADVERSE EVENTS: ADVERSE EVENTS: THE MOST COMMON INJECTION-SITE RESPONSES FOR JUVEDERM ULTRA PLUS XC WERE REDNESS, SWELLING, TENDERNESS, FIRMNESS, LUMPS/BUMPS, DISCOLORATION, AND BRUISING". 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 INJECTION 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 EDEMA, ERYTHEMA, AND PAIN GENERALLY VARIED FROM IMMEDIATE TO 2 MONTHS POST-INJECTION. THE TREATMENT PRESCRIBED INCLUDED NSAIDS, ANTIHISTAMINES, ANTIBIOTICS, STEROIDS, AND HYALURONIDASE. IN MOST CASES, THE REPORTED EVENTS RESOLVED WITHIN A FEW DAYS TO 5 WEEKS".

    Description of Event or Problem · 1

    COMPANY REPRESENTATIVE REPORTED ON BEHALF OF THE HEALTHCARE PROFESSIONAL 3 TO 4 WEEKS AFTER INJECTION WITH "JUVEDERM" IN THE CHEEKS, THE PT EXPERIENCED "SWELLING IN THE FACIAL AREA". STEROIDS WERE USED AS TREATMENT, BUT THE SYMPTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID # 3005113652-2014-00771 (ALLERGAN COMPLAINT PR# (B)(4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVEDERM WHICH WILL BE DEFAULTED TO JUVEDERM ULTRA PLUS XC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17240 JUVEDERM (VOLUME/CONCENTRATION UNKNOWN) LMH ALLEGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention JUVEDERM VOLUMA XC