BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC/L/DO (VOLUME UNK)

    MDR report key: 3779110 · Received April 17, 2014

    Report

    Report Number
    3005113652-2014-00131
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    February 22, 2014
    Report Date
    March 20, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADD'L INFO IS AVAILABLE AT THIS TIME. THE EVENTS OF INFLAMMATION. LUMPS, PAIN, HEAT, ERYTHEMA, FEVER, MALAISE, AND INDURATION ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING: UNDESIRABLE EFFECTS. THE PT MUST BE INFORMED THAT THEY ARE POTENTIAL SIDE EFFECTS ASSOCIATED WITH IMPLANTATION OF THIS PRODUCT, WHICH MAY OCCUR IMMEDIATELY OR MAY BE DELAYED. THESE INCLUDE, BUT ARE NOT LIMITED TO: INFLAMMATORY REACTIONS (REDNESS, OEDEMA, ERYTHEMA, ETC.) WHICH MAY BE ASSOCIATED WITH ITCHING ON PRESSURE OR BOTH, OCCURRING AFTER THE INJECTION. INDURATION OR NODULES AT THE INJECTION SITE. PTS MUST REPORT INFLAMMATORY REACTIONS WHICH PERSIST FOR MORE THAN ONE WEEK OR ANY OTHER SECONDARY EFFECT WHICH DEVELOPS, TO THEIR MEDICAL PRACTITIONER AS SOON AS POSSIBLE. THE MEDICAL PRACTITIONER SHOULD USE AN APPROPRIATE TREATMENT. ANY OTHER UNDESIRABLE SIDE EFFECTS ASSOCIATED WITH INJECTION OF JUVEDERM ULTRA PLUS MUST BE REPORTED TO THE DISTRIBUTOR AND/OR TO THE MFR.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED ONE DAY AFTER INJECTION WITH JUVEDERM ULTRA PLUS IN THE "SHIN/LOWER FACE AREA" AND UNSPECIFIED JUVEDERM VOLUMA IN THE CHEEKS PT NOTED THEIR "CHEEKS WERE SOMEWHAT LUMPY", HEALTHCARE PROFESSIONAL MESSAGE THE LUMPS, TO WHICH THE PT "RESPONDED WELL" AND BOTH PT AND HEALTHCARE PROFESSIONAL WERE "SATISFIED." APPROX THREE WEEKS LATER, PT'S CHIN BECAME "MONSTROUS LOOKING AND SORE." PT WAS ASSESSED BY THE HEALTHCARE PROFESSIONAL WHO NOTED THE PT HAD DEVELOPED SWELLING OF THE CHEEKS AND CHIN AS WELL AS "8 SIGNIFICANT INDIVIDUAL LUMPS IN THE FACE, 3 ON [THE PT'S] LEFT CHEEK, 2 ON [THE PT'S] RIGHT CHEEK, 1 LARGE [LUMP] ON THE RIGHT SIDE OF [THE PT'S] CHIN, AND 2 ON THE LEFT SIDE OF [THE PT'S] CHIN." THE LUMPS RANGED IN SIZE FROM 1 X 1 CM TO 3 X 4 CM IN DIAMETER. THE PT'S FACE "FELT HOT, SORE, AND [THE PT'S] SKIN WAS RED OVER THE LUMPS." PT INDICATED THEY FELT 'FEVERISH AS IF [THEY] HAD A MAJOR SUNBURN" AND HAD "GENERAL MALAISE." THE LUMPS WERE FURTHER DESCRIBED AS "BIG HARD, AND SORE". PT WAS PRESCRIBED "A MIX OF HYALURONIDASE 1500UL/ML + KENALOG 10 MG/ML + LIDOCAINE 2%." TWO DAYS LATER THE "BURNING HAD STOPPED", THERE WAS NO MORE HEAT" BUT THE PT WAS STILL SORE. "ALL THE LUMPS WERE SIGNIFICANTLY REDUCED IN SIZE RANGING FROM 5 X 1 CM TO 1 X 1 CM." PT WAS TREATED AGAIN "WITH THE SAME MIX AS BEFORE." OVER THE COURSE OF THE NEXT WEEK, PT NOTED "THAT THE SWELLING WENT DOWN EVEN FURTHER ALTHOUGH IT IS NOT YET BACK TO NORMAL". THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID # .005113652-2014-00144 (ALLERGAN COMPLAINT (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT. JUVEDERM ULTRA PLUS ALSO A DEVICE MANUFACTURED BY ALLERGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236435 JUVEDERM ULTRA PLUS XC/L/DO (VOLUME UNK) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention BOTOX INJECTION IN FOREHEAD, "BROW LIFT", AND CHIN| JUVEDERM VOLUMA