BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC/LIDO (VOUME UNK)

    MDR report key: 4162887 · Received October 8, 2014

    Report

    Report Number
    3005113652-2014-00500
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    January 27, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION FORM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF SCAR, NECROSIS, SCLERITIS, "TWO BLEMISHES [THAT] GOT VERY ANGRY", "AREA TURNED DARK", ERYTHEMA, AND SWELLING 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: THE MOST COMMON INJECTION-SITE RESPONSES FOR JUVEDERM ULTRA PLUS XC WERE REDNESS, SWELLING, TENDERNESS, FIRMNESS, LUMPS/BUMPS, DISCOLORATION, AND BRUISING. POST-MARKET SURVEILLANCE: ADVERSE EVENTS WITH A FREQUENCY 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. 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 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 FORM 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. ADDITIONALLY THERE HAVE BEEN REPORTS OF NODULES, INFECTION, AND INFLAMMATION. THE ONSET OF INFLAMMATION GENERALLY VARIED FROM THE DAY OF TREATMENT TO 1 DAY POST-INJECTION. THE TREATMENT PRESCRIBED INCLUDED ANTIBIOTICS, STEROIDS, AND NEEDLE ASPIRATION. RESOLUTION OF SYMPTOMS HAS BEEN REPORTED WITHIN 4 DAYS. PHYSICIAN INSTRUCTIONS: THE PHYSICIAN SHOULD INSTRUCT THE PT TO PROMPTLY REPORT TO HER/HIM ANY EVIDENCE OF PROBLEMS POSSIBLY ASSOCIATED WITH THE USE OF JUVEDERM ULTRA PLUS XC.

    Description of Event or Problem · 1

    PT REPORTED APPROXIMATELY 1 MONTH AFTER INJECTION IN THE NASOLABIAL FOLDS WITH JUVEDERM ULTRA PLUS XC THEY DEVELOPED NECROSIS AT THE LEFT NASOLABIAL FOLD AND "RED EYE" WHICH WAS DIAGNOSED AS SCLERITIS. PT WAS PRESCRIBED BACTRIM DS AND INSTRUCTED TO APPLY AQUAPHOR TO THE "AFFECTED AREA". ABOUT 1.5 MONTHS AFTER SYMPTOM ONSET, THE SITE HEALED AND THE PT SOUGHT THE CARE OF A PLASTIC SURGEON FOR SCAR REVISION. FOLLOW UP WITH THE PLASTIC SURGEON NOTED UPON INITIAL ASSESSMENT ONLY A RED SCAR WAS PRESENT AT THE PT'S LEFT NASOLABIAL FOLD. AN OPHTHALMOLOGIC EXAM SHOWED THE "EYELIDS AND CONJUNCTIVE [WERE] CLEAR". THE PLASTIC SURGEON TREATED THE PT WITH HYALURONIDASE, FOLLOWED APPROXIMATELY ONE MONTH LATER WITH BACTRIM, TO WHICH THE PT HAD A "REACTION". SUBSEQUENTLY THE PT WAS PRESCRIBED ACLOVATE 0.05 PERCENT TOPICAL CREAM. BETWEEN THE HYALURONIDASE AND BACTRIM, THE PT ALSO BEGAN A "BIO-SERUM" REGIMEN OF THEIR OWN VOLITION. A SCAR REVISION PROCEDURE WAS PERFORMED BY THE PLASTIC SURGEON, WHICH RESULTED IN "EXTREME IMPROVEMENT" AND A PLAN FOR THE PT TO BEGIN SKIN MEDICA SCAR GEL WAS PUT IN PLACE. "THERE WAS NO EVIDENCE OF FURTHER LESION". THE PLASTIC SURGEON STATED THAT THE PT INFORMED THEM SYMPTOMS BEGAN AS "TWO BLEMISHES [THAT] GOT VERY ANGRY, RED/SWOLLEN' AND THEN THE ARE "TURNED DARK AND OPEN". AS THE PLASTIC SURGEON DID NOT OBSERVE THESE SYMPTOMS PERSONALLY, BUT ONLY THE AFTERMATH OF THE SCAR, THE ETIOLOGY OF THE SYMPTOMS COULD NOT BE CONCRETELY DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631439 JUVEDERM ULTRA PLUS XC/LIDO (VOUME UNK) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention| S MICRONOR BCP| "BIRTH CONTROL"| VITAMIN E