BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML

    MDR report key: 3850573 · Received May 22, 2014

    Report

    Report Number
    3005113652-2014-00224
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 FEELING "UNDER THE WEATHER", SWELLING, "INTERMITTENT HEAT SENSATION", TENDERNESS, AND POSSIBLE "FACIAL WEAKNESS" 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 PHYSIOCHEMICAL AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. THE STERILIZATION CYCLE IS REGISTERED AS CONFORMING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THREE DAYS AFTER INJECTION WITH JUVEDERM VOLUMA XC IN THE CHEEKS, JUVEDERM VOLVELLA WITH LIDOCAINE IN THE BILATERAL PERIORBITAL AREA, AND BOTOX IN THE GLABELLA, CROW'S FEET, FRONTAILS AND "BUNNYS", THE PATIENT BEGAN TO FEEL "UNDER THE WEATHER". PATIENT REPORTED THEY HAD A SORE THROAT AND HAD A SENSATION THAT THEIR GLANDS WERE BEGINNING TO SWELL. THE PATIENT ALSO DEVELOPED A SENSATION OF INTERMITTENT HEAT AT THE RIGHT CHEEK AS WELL AS SWELLING AND TENDERNESS OF THE RIGHT CHEEK AND LOWER FACE; THE AREA WAS NOT RED OR "HOT TO PALPATE". UPON ASSESSMENT, THE HEALTHCARE PROFESSIONAL NOTED THE PATIENT EXPERIENCED DIFFICULTY "WITH ELEVATION OF RIGHT SIDE UPPER LIP EITHER DUE TO FACIAL WEAKNESS OR MOVEMENT RESTRICTED DUE TO SWELLING". THREE DAYS AFTER SYMPTOM ONSET, THE PATIENT WAS PRESCRIBED "ANTIBIOTICS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306522 JUVEDERM VOLUMA WITH LIDOCAINE 1ML LMH ALLERGAN NA VB20A30323

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention JUVEDERM VOLBELLA| LIDOCAINE| BOTOX