BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC TSK US

    MDR report key: 4223538 · Received October 29, 2014

    Report

    Report Number
    3005113652-2014-00552
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 2, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 EVENTS OF SWELLING, TENDERNESS, PAIN, AND "YELLOWISH PINKISH FLUCTUANT MASS" WHICH LOOKED LIKE AN ABSCESS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MFG STEPS AND ALL THE PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED ON THE EVENING OF INJECTION IN THE NASOLABIAL FOLDS AND "PERIORAL RISES" WITH JUVEDERM ULTRA XC, THE PT EXPERIENCED "SWELLING AND A LOT OF TENDERNESS" ON THE "ENTIRE RIGHT SIDE" OF THE FACE. THREE DAYS LATER, THE PT WAS TREATED WITH HYALURONIDASE, DOXYCYCLINE AND A MEDROL DOSEPAK. FOUR DAYS AFTER TREATMENT WAS PRESCRIBED, THE HEALTHCARE PROFESSIONAL NOTED THE PT DEVELOPED WHAT LOOKED LIKE AN ABSCESS ON HER GUM LINE. PER THE HEALTHCARE PROFESSIONAL, "IT'S LIKE A CYST, PAINFUL, YELLOWISH, PINKISH 1.5 CM FLUCTUANT MASS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692172 JUVEDERM ULTRA XC TSK US LMH ALLERGAN NA H24LA40172

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SYNTHROID| BOTOX