BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC 0,8ML (1 ML COC)

    MDR report key: 2950231 · Received February 6, 2013

    Report

    Report Number
    3005113652-2013-00005
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    December 24, 2012
    Report Date
    November 29, 2016
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD REVIEW SUMMARY: THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THESE REACTIONS: ALL THE MANUFACTURING STEPS AND ALL THE PHYSIOCHEMICAL 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. DEVICE LABELING: UNDESIRABLE EFFECTS: MEDICAL PRACTITIONERS MUST INFORM THE PT THAT THERE ARE POTENTIAL SIDE EFFECTS ASSOCIATES WITH IMPLANTATION OF THIS PRODUCT, WHICH MAY OCCUR IMMEDIATELY OR MAY BE DELAYED. THESE INCLUDE, BUT ARE NOT LIMITED TO: INDURATION OR NODULES AT THE INJECTION SITE. CASES OF NECROSES IN THE GLABELLAR REGION, ABSCESSES, GRANULOMA AND IMMEDIATE OR DELAY HYPERSENSITIVITY AFTER HYALURONIC ACID AND/OR LIDOCAINE INJECTIONS HAVE BEEN REPORTED. IT IS THEREFORE ADVISABLE TO TAKE THESE POTENTIAL RISKS INTO ACCOUNT. PTS MUST REPORT INFLAMMATORY REACTIONS WHICH PERSIST FOR MORE THAN ONE WEEK, OR ANY OTHER SIDE EFFECT WHICH DEVELOPS, TO THEIR MEDICAL PRACTITIONER AS SOON AS POSSIBLE. THE MEDICAL PRACTITIONER SHOULD USE AN APPROPRIATE TREATMENT.

    Description of Event or Problem · 1

    TREATING PHYSICIAN REPORTED ASSESSING PT WHO HAD BEEN INJECTED WITH JUVEDERM ULTRA PLUS XC IN THE MEDIAL NASOLABIAL FOLDS, MARIONETTE LINES, AND UPPER LIP BY ANOTHER PHYSICIAN. APPROXIMATELY FIVE WEEKS AFTER THE INITIAL DERMAL FILLER INJECTION, THE PT DEVELOPED A SINGLE LUMP IN THE NASOLABIAL FOLD, WHICH VERY RAPIDLY SPREAD TO ALL OTHER TREATED AREAS RESULTING IN A VERY SWOLLEN FACE. THE PT NOTED THAT THE INJECTING PHYSICIAN DID NOT INITIALLY RESPOND TO THE PT'S CALLS FOR A FOLLOW UP CONSULTATION, SO THE PT SOUGHT TREATMENT INITIALLY FROM THE REPORTING PHYSICIAN. THE PT WAS DIAGNOSED WITH AN ALLERGIC REACTION (REDNESS AND SWELLING) AND TREATED WITH 35 IU HYALASE, AMOXICILLIN AND CEFALEXIN. THE TREATING PHYSICIAN NOTED THAT THE SYMPTOMS WERE DESCRIBED AS ONGOING AND PRESENTING MOST RECENTLY IN THE "RIGHT HAD SIDE UPPER LIP". ADDITIONALLY THE EVENT IS REPORTED TO NOT BE CONSIDERED A LIFE THREATENING INJURY NOR DID IT CAUSE PERMANENT INJURY AT THIS TIME. AFTER SEEING THE REPORTING PHYSICIAN THE PT ALSO SOUGHT TREATMENT FROM THE INJECTION PHYSICIAN WHO TREATED THE PT WITH ANOTHER INJECTION OF HYALASE. THE INJECTING PHYSICIAN INDICATED THAT THE "PT STILL HAS SIGNIFICANT DEFORMITIES" BUT THE SWELLING WAS SLOWLY SUBSIDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50704 JUVEDERM ULTRA PLUS XC 0,8ML (1 ML COC) IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN NA H30L864081

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention| S