BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2 X 1ML

    MDR report key: 4092044 · Received August 21, 2014

    Report

    Report Number
    3005113652-2014-00411
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 31, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF TENDERNESS, HOT TO TOUCH, PUSTULE-LIKE SPOTS, INFECTION, HEMATOMA, ERYTHEMA, SWELLING, INDURATION, AND NODULARITY ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED 4 DAYS AFTER INJECTION WITH JUVEDERM VOLUMA XC IN THE "LATERAL ZYGOMATIC" AND RIGHT "INNER LOWER ORBITAL RIM" AS WELL AS CONCOMITANT BOTOX IN THE GLABELLA THE PT WOKE UP AND NOTED THE AREA WAS "VERY SWOLLEN", ERYTHEMATOUS, INDURATED, AND FELT HOT TO TOUCH". THE PT ALSO NOTED INCREASING TENDERNESS OF THE LEFT CHEEK AND "PUSTULE-LIKE SPOTS". THE HEALTHCARE PROFESSIONAL THOUGHT THE PT COULD BE SHOWING SIGNS OF AN "EARLY INFECTION VS HEMATOMA WITH SWELLING". THE PT WAS PRESCRIBED "CIPRO" AND DIFLUCAN. THE HEALTHCARE PROFESSIONAL HAS ONLY BEEN ABLE TO MONITOR THE PT VIA PHONE AND PHOTOS AS THE PT LIVES 6 HOURS AWAY FROM THE OFFICE. WITH TREATMENT, THE "ERYTHEMA, SWELLING, AND INDURATION ARE DOWN, BUT THE NODULARITY IN THE LOWER INNER [LEFT] CHECK NEAR THE NOSE REMAINS". THE PT HAD BEEN INJECTED WITH 2 SYRINGES OF JUVEDERM VOLUMA XC FOR "BILATERAL CHEEK AUGMENTATION" FOUR DAYS PRIOR TO THE INJECTION NOTED ABOVE; THERE WERE "NO ISSUES UPON COMPLETION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504527 JUVEDERM VOLUMA XC 27G 2 X 1ML LMH ALLERGAN NA VB20A40007

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention OTOX, "STANDARD SKIN CLEANING TECHNIQUE"