BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC (1 ML COC)

    MDR report key: 5411917 · Received February 4, 2016

    Report

    Report Number
    3005113652-2016-00037
    Event Type
    Injury
    Date Received
    February 4, 2016
    Date of Event
    January 14, 2016
    Report Date
    January 15, 2016
    Manufacturer
    ALLERGAN (PRINGY)
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 02/04/2016. 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 SMALL BLOOD BLISTER, SWELLING AND DISCOLORATION 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 FOR THE REPORTED EVENTS OF SKIN INFLAMMATION, EDEMA AND SKIN DISCOLORATION: "UNDESIRABLE EFFECTS THE PATIENTS MUST BE INFORMED THAT THERE ARE POTENTIAL SIDE EFFECTS ASSOCIATED WITH IMPLANTATION OF THIS PRODUCT, WHICH MAY OCCUR IMMEDIATELY OR MAY BE 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. ¿ STAINING OR DISCOLOURATION OF THE INJECTION SITE."

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH JUVÉDERM ULTRA¿ XC IN THE UPPER AND LOWER LIPS. PRIOR TO INJECTION, THE PATIENT WAS TREATED WITH "LMX." PATIENT DEVELOPED A "SMALL BLOOD BLISTER" ON THE DAY OF INJECTION THAT "SETTLED." THE NEXT MORNING THE PATIENT REPORTED TO THE HEAD NURSE THAT THEIR "LIPS SWOLLEN AND DISCOLOURATION TO THE CHIN." PATIENT WAS TREATED WITH HYALASE. SYMPTOMS ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67636 JUVEDERM ULTRA XC (1 ML COC) IMPLANT, DERMAL, FOR AESTHETIC USE LMH ALLERGAN (PRINGY) H24LA50411

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention