BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION UNKNOWN)

    MDR report key: 4142576 · Received September 30, 2014

    Report

    Report Number
    3005113652-2014-00483
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALLERGAN IS UNABLE TO CONFIRM WITH THE HEALTHCARE PROFESSIONAL, THEREFORE ADDITIONAL EVENT, PRODUCT, OR PATIENT DETAILS ARE NOT ATTAINABLE. THE EVENTS OF "SWELLING" AND "BRUISING" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING: INTENDED USE/INDICATIONS JUVEDERM ULTRA XC INJECTABLE GEL IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS). WARNINGS: INJECTION PROCEDURE REACTIONS CONSIST MAINLY OF SHORT-TERM INFLAMMATORY SYMPTOMS STARTING EARLY AFTER TREATMENT AND LASTING <_ 7 DAYS' DURATION. PRECAUTIONS: THE SAFETY AND EFFECTIVENESS FOR THE TREATMENT OF ANATOMIC REGIONS OTHER THAN FACIAL WRINKLES AND FOLDS (EG, LIPS) HAVE NOT BEEN ESTABLISHED IN CONTROLLED CLINICAL STUDIES. ADVERSE EVENTS: THE MOST COMMON INJECTION-SITE RESPONSES FOR JUVEDERM ULTRA XC WERE REDNESS, SWELLING, TENDERNESS, FIRMNESS, LUMPS/BUMPS, DISCOLORATION, AND BRUISING. POSTMARKET SURVEILLANCE: SERIOUS ADVERSE EVENTS HAVE INFREQUENTLY BEEN REPORTED FOR JUVEDERM ULTRA (REPORTED WITH A FREQUENCY OF 5 OR MORE). THE MORE COMMONLY REPORTED SERIOUS ADVERSE EVENTS WERE EDEMA, ERYTHEMA, ECCHYMOSIS, PRURITUS, INDURATION, AND PAIN. THE ONSET OF EDEMA GENERALLY VARIED FROM IMMEDIATE TO 2 WEEKS POST-INJECTION. THE TREATMENT PRESCRIBED INCLUDED ARNICA, NSAIDS, ANTIHISTAMINES, ANTIBIOTICS, STEROIDS, AND HYALURONIDASE. IN MOST CASES, EDEMA RESOLVED WITHIN A DAY TO A MONTH. THE ONSET OF ECCHYMOSIS GENERALLY VARIED FROM IMMEDIATE TO 5 DAYS POST-INJECTION. THE TREATMENT PRESCRIBED INCLUDED ARNICA, NSAIDS, ANTIHISTAMINES, ANTIBIOTICS, STEROIDS, AND HYALURONIDASE. IN MOST CASES, ECCHYMOSIS RESOLVED WITHIN 1 DAY TO 4 WEEKS.

    Description of Event or Problem · 1

    PATIENT REPORTED AFTER INJECTION IN THE LIPS WITH JUVEDERM, THEY EXPERIENCED "SWELLING" AND BRUISING" AT THE INJECTION SITE. THE PATIENT NOTED AFTER INJECTION, THEY STARTED ICING THEIR LIPS, AND NOTICED THAT THEIR LIPS ARE "DOUBLE THE SIZE OF WHAT THEY ARE EXPECTING". THE PATIENT WAS TREATED WITH A MEDROL DOSEPAK AND ARNICA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608123 JUVEDERM (VOLUME/CONCENTRATION UNKNOWN) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention