BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC 1 ML ROW

    MDR report key: 5096336 · Received September 23, 2015

    Report

    Report Number
    3005113652-2015-00553
    Event Type
    Injury
    Date Received
    September 23, 2015
    Date of Event
    May 15, 2015
    Report Date
    September 2, 2015
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 09/22/2015. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENTS OF PAIN AND EDEMA ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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 PHYSICOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING. DEVICE LABELING ADDRESSES THE REPORTED EVENTS OF PAIN AND EDEMA AS FOLLOWS: 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."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED PRIOR TO INJECTION PATIENT WAS PRETREATED WITH DERMOMAX AND THEN INJECTED TO THE LIPS AND LIPS CONTOUR FOR VOLUME WITH JUVÉDERM ULTRA¿ XC. PATIENT WAS CONCOMITANTLY INJECTED TO THE MALAR AND MENTO REGION WITH JUVÉDERM® VOLUMA¿ WITH LIDOCAINE. PATIENT USED ICE AFTER INJECTION. EIGHT MONTHS LATER PATIENT DEVELOPED A ¿LATE REACTION¿ AND ¿PAIN AND MILD MALAR EDEMA IN LEFT SIDE¿ AND SWELLING IN THE UPPER LIP. PATIENT WAS TREATED WITH PREDSIM IN DECREASING DOSAGES. PATIENT HAS HAD 3 "OUTBREAKS" IN THE LAST 4 MONTHS. SYMPTOMS ARE ONGOING. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 3005113652-2015-00554 (ALLERGAN COMPLAINT PR#1231025). THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT, JUVÉDERM ULTRA¿ XC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627818 JUVEDERM ULTRA XC 1 ML ROW IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) H24LA40125

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention DERMOMAX, JUVÉDERM® VOLUMA¿