BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK ROW

    MDR report key: 2247602 · Received September 9, 2011

    Report

    Report Number
    3005113652-2011-00073
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION SUMMARY: THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MANUFACTURING STEPS AND ALL THE PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING. THE ATTRIBUTABILITY IS THEN IMPOSSIBLE TO DETERMINE.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THAT AFTER INJECTION WITH JUVEDERM ULTRA XC IN THE "FACE, MELOLAB MARIONETTE JOWLS", THE PATIENT EXPERIENCED AN INDURATION THAT WAS TREATED WITH INTRALESIONAL KENALOG AND PREDNISONE TO PREVENT WORSENING OF SYMPTOMS THAT MAY HAVE LED TO PERMANENT DAMAGE, AND TO HASTEN RESOLUTION OF THE SYMPTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA PLUS XC TSK ROW LMH ALLERGAN NA H30L636651

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention