BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC 1 ML ROW

    MDR report key: 3242908 · Received July 19, 2013

    Report

    Report Number
    3005113652-2013-00092
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD 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. DEVICE LABELING: UNDESIREABLE EFFECTS: CASES OF NECROSES IN THE GLABELLAR REGION, ABSCESS, GRANULOMA, AND IMMEDIATE OR DELAYED HYPERSENSITIVITY AFTER HYALURONIC ACID AND/OR LIDOCAINE INJECTIONS HAVE BEEN REPORTED. IT IS THEREFORE ADVISABLE TO TAKE THESE POTENTIAL RISKS INTO ACCOUNT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AN HOUR AND A HALF AFTER INJECTION IN THE NASOLABIAL FOLDS WITH JUVEDERM ULTRA PLUS XC, PATIENT EXPERIENCED AN ALLERGIC REACTION "FROM EYES TO LIPS DOWN, AND CHEEKS". PATIENT WENT TO "URGENT CARE" WHERE, DURING THE COURSE OF FOUR HOURS "BETAMETAZONE AND INTRAVENOUS CLORFENAMINS" WERE ADMINISTERED. PATIENT LEFT "URGENT CARE" WITH A PRESCRIPTION FOR "INTRAMUSCULAR CLORFENAMIS". TREATMENT WAS CONSIDERED "100% EFFECTIVE" AFTER 5 DAYS OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338879 JUVEDERM ULTRA PLUS XC 1 ML ROW LMH ALLERGAN NA H30LA20020

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention