BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK ROW

    MDR report key: 3060187 · Received April 11, 2013

    Report

    Report Number
    3005113652-2013-00048
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    September 30, 2012
    Report Date
    November 23, 2012
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY REPORT 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: PRECAUTIONS FOR USE: THERE IS NO AVAILABLE CLINICAL DATA CONCERNING THE TOLERANCE OF THE JUVEDERM ULTRA PLUS XC INJECTION IN PATIENTS PRESENTING A HISTORY OF SEVERE MULTIPLE ALLERGIES OR ANAPHYLACTIC SHOCK. THE MEDICAL PRACTITIONER SHALL THEREFORE DECIDE ON THE INDICATION ON A CASE-BY-CASE BASIS, ACCORDING TO THE NATURE OF THE ALLERGY, AND SHALL ALSO ENSURE THE SPECIFIC MONITORING OF THESE AT-RISK PATIENTS. IN PARTICULAR, THE DECISION MAY BE TAKEN TO PROPOSE A DOUBLE TEST. UNDESIRABLE EFFECTS: THE PATIENT MUST BE INFORMED THAT THERE ARE POTENTIAL SIDE EFFECTS LINKED TO THIS PROCEDURE, WHICH CAN BE EITHER IMMEDIATE OR DELAYED. THESE INCLUDE BUT ARE NOT LIMITED TO: INFLAMMATORY REACTIONS (REDNESS, OEDEMA, ERYTHEMA, ETC.) WHICH MAY BE ASSOCIATED WITH ITCHING OR PAIN ON PRESSURE OR BOTH, OCCURRING AFTER THE INJECTION. THESE REACTIONS MAY LAST FOR A WEEK. HAEMATOMAS. INDURATION OR NODULES AT THE INJECTION SITE. PATIENTS MUST REPORT INFLAMMATORY REACTIONS WHICH PERSIST FOR MORE THAN ONE WEEK OR ANY OTHER SECONDARY EFFECT WHICH DEVELOPS, TO THEIR MEDICAL PRACTITIONER AS SOON AS POSSIBLE. THE MEDICAL PRACTITIONER SHOULD TREAT THESE AS APPROPRIATE. ANY OTHER UNDESIRABLE SIDE EFFECTS ASSOCIATED WITH INJECTION OF JUVEDERM ULTRA PLUS XC MUST BE REPORTED TO THE DISTRIBUTOR AND/OR TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED ONE MONTH AFTER PATIENT WAS INJECTED IN THE PRE-JOWLS AREA, "CHECKS", "RADIZ", AND "SNG" WITH 1 SYRINGE OF JUVEDERM ULTRA PLUS XC AND TWO SYRINGES OF JUVEDERM VOLUMA THEY DEVELOPED INDURATION IN THE PRE-JOWL AREA. THREE MONTHS AFTER THE JUVEDERM INJECTIONS THE PATIENT DEVELOPED "EDEMA AND LOCAL HEAT" STARTING IN THE INFRAORBITAL REGION. PATIENT WAS TREATED WITH DIPROFOS AND "LEVOCITIRIZIN". THE REPORTED EDEMA HAS DECREASED SINCE THE LAST VISUAL EXAM YET THE SYMPTOMS HAVE NOT FULLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156137 JUVEDERM ULTRA PLUS XC TSK ROW LMH ALLERGAN NA H30L730218

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention JUVEDERM VOLUMA