BEUDAMED
    FDA Adverse Event Other Summary report: N

    JUVEDERM ULTRA PLUS

    MDR report key: 1202757 · Received October 10, 2008

    Report

    Report Number
    3005113652-2008-00063
    Event Type
    Other
    Date Received
    October 10, 2008
    Date of Event
    May 8, 2008
    Report Date
    August 1, 2008
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 THIS REACTION: ALL THE MANUFACTURING STEPS AND ALL THE PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN, STERILITY TEST, STERILISATION CYCLE) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS.

    Description of Event or Problem · 1

    A PATIENT WAS TREATED WITH JUVEDERM ULTRA PLUS IN THE NASOLABIAL FOLDS AND MARIONETTE LINES AND ABOUT ONE MONTH LATER WAS TREATED WITH COSMOPLAST IN THE FINE LINES AND LIPS. ABOUT TWO WEEKS AFTER TREATMENT WITH COSMOPLAST, THE PATIENT PRESENTED WITH MILD RED STREAKS AND A RED CRESCENT AT THE BOTTOM OF THE NASOLABIAL FOLDS WHERE BOTH PRODUCTS WERE PLACED. NO TREATMENT HAS BEEN GIVEN . THE PATIENT FEELS THE WRINKLE LOOKS WORST WHERE THE COSMOPLAST WAS TREATED. FOLLOW-UP WITH THE PHYSICIAN NOTED THAT AFTER THE JUVEDERM ULTRA PLUS TREATMENT THE PATIENT HAD PRESENTED WITH A LUMP ON THE LEFT SIDE OF THE LIPS. TWO MONTHS AFTER THE COSMOPLAST TREATMENT, THE PATIENT PRESENTED WITH INDENTS IN THE MARIONETTE LINES. AFTER FURTHER FOLLOW-UP WITH THE PHYSICIAN, IT WAS STATED THAT THIS IS AN "UNUSUAL EVENT' AND WAS NOT DUE TO PRODUCT MIGRATION OR LUMPING OF PRODUCT. THE PHYSICIAN ALSO NOTED THE INDENTS ARE LITERALLY INDENTED INTO THE PATIENT'S FACE. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 2024601-2008-00784 (ALLERGAN COMPLAINT (B) (4)). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA PLUS JUVEDERM LMH PRINGY NA HV30466025

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Disability VITAMIN E| ADVIL