BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC 1 ML ROW

    MDR report key: 3834587 · Received May 2, 2014

    Report

    Report Number
    3005113652-2014-00166
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 8, 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

    FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADD'L INFO IS AVAILABLE AT THIS TIME. THE EVENTS OF ISCHEMIA, SKIN BREAKDOWN, "ACNEIFORM PAPULES," EDEMA, ERYTHEMA, BLANCHING, BRUISING, AND PAIN ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED DURING INJECTION WITH JUVEDERM ULTRA PLUS XC IN THE NASOLABIAL FOLDS THE PT DEVELOPED "POOR CAPILLARY REFILL" ON THE RIGHT SIDE. THE PT ALSO DEVELOPED "SOME BURNING PAIN AROUND THE NASAL FLARE" AND ALONG THE NASOLABIAL FOLD ON THE RIGHT SIDE AS WELL AS BRUISING AND SWELLING. AS THERE APPEARED TO BE SOME AREAS OF BLANCHING SUGGESTING ISCHEMIA, THE PT WAS IMMEDIATELY INJECTED WITH HYALURONIDASE. ADD'L TREATMENTS INCLUDING "ASA, NITROPASTE, AND WARM COMPRESSES TO THE AREA" AS WELL AS CIPROFLOXACIN AND FUCIDIN WERE ALSO PRESCRIBED. THE FOLLOWING DAY THE PT "SHOWED IMPROVEMENT" AND THEIR PAIN "SIGNIFICANTLY LESSENED." TWO DAYS AFTER INJECTION THE PT AWOKE "COMPLAINING OF INCREASING PAIN AGAIN ALONG" THEIR NASOLABIAL FOLDS AND THE RIGHT SIDE OF THEIR NOSE. PT WAS TREATED WITH ADD'L HYALURONIDASE. OVER THE NEXT FEW DAYS THE PT BEGAN TO RUB THE AREA "WITH A NAPKIN" AND THEIR SKIN BEGAN "SUPERFICIALLY STARTING TO BREAK DOWN." THERE WAS ALSO EVIDENCE OF "ACNEIFORM PAPULES." PT WAS INSTRUCTED BY THE HEALTHCARE PROFESSIONAL TO NOT MASSAGE THE AREA OR APPLY MAKE-UP AND TO "APPLY POLYSPORIN." PT SYMPTOMS HAVE IMPROVED BUT THERE IS STILL SOME "RESIDUAL REDNESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265284 JUVEDERM ULTRA PLUS XC 1 ML ROW LMH ALLERGAN NA H30LA30253

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention "VITAMINS"| CHLORHEXIDINE