BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC TSK US

    MDR report key: 3010324 · Received March 14, 2013

    Report

    Report Number
    3005113652-2013-00023
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 15, 2012
    Report Date
    February 9, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY REVIEW 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. DEVICE LABELING: ADVERSE EVENTS: THE MOST COMMON INJECTION-SITE RESPONSES FOR JUVEDERM ULTRA XC WERE REDNESS, SWELLING, TENDERNESS, FIRMNESS, LUMPS/BUMPS, DISCOLORATION, AND BRUISING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INJECTION OF THE RIGHT AND LEFT MALARS WITH 1 SYRINGE OF JUVEDERM ULTRA XC, THE PATIENT REPORTED OBSERVING "PERIOCULAR BLUING AND PROGRESSIVE SWELLING" APPROXIMATELY 4 MONTHS LATER. THE INJECTOR FEELS THAT THE SYMPTOMS WERE POSSIBLY A CUMULATIVE EFFECT OF SEVERAL INJECTIONS OF DERMAL FILLER TO THE SAME AREA OVER A SPAN OF SEVERAL YEARS, ALTHOUGH THE SYMPTOMS DID NOT APPEAR UNTIL AFTER THIS MOST RECENT INJECTION. THE PATIENT SYMPTOMS WERE TREATED WITH VITRASE APPROXIMATELY A YEAR AFTER APPARITION TO "RESOLVE THE PROBLEM" WHICH WAS "WORSENING". AFTER TREATMENT SYMPTOMS RESOLVED WITH A RETURN TO THE PATIENT'S "NATIVE ANATOMY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108160 JUVEDERM ULTRA XC TSK US LMH ALLERGAN NA H24L636654

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention