BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 4212958 · Received October 24, 2014

    Report

    Report Number
    3005113652-2014-00548
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 28, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ALLERGAN
    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

    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 GRAY SKIN DISCOLORATION, "PUSTULES", "ARTERIAL OCCLUSION", ERYTHEMA, AND SWELLING ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. DEVICE LABELING: WARNINGS: THE PRODUCT MUST NOT BE INJECTED INTO BLOOD VESSELS. INTRODUCTION OF JUVEDERM ULTRA PLUS XC INTO THE VASCULATURE MAY OCCLUDE THE VESSELS AND COULD CAUSE INFARCTION OR EMBOLIZATION. INJECTION PROCEDURE REACTIONS CONSIST MAINLY OF SHORT-TERM INFLAMMATORY SYMPTOMS STARTING EARLY AFTER TREATMENT AND LASTING LESS THAN 7 DAYS' DURATION. REFER TO THE ADVERSE EVENTS SECTION FOR DETAILS. ADVERSE EVENTS: THE MOST COMMON INJECTION-SITE RESPONSES FOR JUVEDERM ULTRA PLUS XC WERE REDNESS, SWELLING, TENDERNESS, FIRMNESS, LUMPS/BUMPS, DISCOLORATION, AND BRUISING. POSTMARKET SURVEILLANCE: THE FOLLOWING ADVERSE EVENTS WERE RECEIVED FROM POSTMARKET SURVEILLANCE FOR JUVEDERM ULTRA PLUS (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. NECROSIS HAS MOSTLY BEEN REPORTED AFTER TREATMENT IN THE FOREHEAD OR GLABELLAR REGION AND ASSOCIATED WITH A VASCULAR EVENT, SKIN DISCOLORATION, BLISTER, PAIN, SCAR, OR INFECTION. TIME TO ONSET RANGED FROM 1 TO 3 DAYS POST JUVEDERM ULTRA PLUS INJECTION, AND OUTCOME RANGED FROM RESOLVED WITH LITTLE TO NO RESIDUAL EFFECTS TO SCARRING AT THE TREATMENT SITE. INTERVENTIONS PRESCRIBED BY THE PHYSICIANS INCLUDED TOPICAL STEROIDAL CREAM, ANTIBACTERIAL OINTMENT OR CREAM, NITROPASTE, ORAL STEROIDS, ASPIRIN, AND ORAL OR INJECTABLE ANTIBIOTICS. ADDITIONAL TREATMENTS NOTED WERE INJECTABLE HYALURONIDASE, LASER RESURFACING, TISSUE DEBRIDEMENT, AND SURGICAL SCAR REVISION. 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

    HEALTHCARE PROFESSIONAL REPORTED 3-4 DAYS AFTER INJECTION WITH JUVEDERM ULTRA PLUS XC IN THE NASOLABIAL FOLDS THE PT PRESENTED TO THE OFFICE STATING THAT THE LEFT NASOLABIAL FOLD "TURNED GRAY". THAT NIGHT THE PT VISITED THE EMERGENCY ROOM AND WAS TREATED WITH ANTIBIOTICS. FOUR DAYS LATER, THE PT AGAIN PRESENTED TO THE HEALTHCARE PROFESSIONAL WITH WHAT LOOKED LIKE LEFT SIDED ERYTHEMA, SWELLING, "PUSTULES AND CELLULITIS IN THE TREATMENT AREA" EXTENDING FROM THE NASOLABIAL FOLDS DOWN TO THE MARIONETTE LINES. THE PT WAS ADMITTED TO THE HOSPITAL FOR 3-4 DAYS WHERE THEY WERE TREATED WITH IV VANCOMYCIN AS WELL AS NITROPASTE AND VIAGRA. THE PT "GOT PROGRESSIVELY BETTER" WITH TREATMENT; THE HEALTHCARE PROFESSIONAL ULTIMATELY BELIEVED THE PUSTULES, ERYTHEMA, SWELLING, AND SKIN DISCOLORATION WERE DUE TO AN "OCCLUSION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678894 JUVEDERM ULTRA PLUS XC TSK US LMH ALLERGAN NA H30LA40191

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| R