BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA XC 27G 2X1ML

    MDR report key: 4172816 · Received October 10, 2014

    Report

    Report Number
    3005113652-2014-00517
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: 10/10/2014. FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INO IS AVAILABLE AT THIS TIME. THE EVENTS OF ABSCESS, DISCHARGE, INDURATION, SWELLING AND PAIN ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED 6 DAYS AFTER INJECTION IN THE CHEEKS WITH TWO SYRINGES OF JUVEDERM VOLUMA XC, THE PT EXPERIENCED PAIN AND "SWELLING AND INDURATION AT THE INJECTION SITE". THE SAME DAY AS SYMPTOM OCCURRENCE, THE PT SELF-TREATED WITH BENADRYL AND WAS ALSO SEEN BY THE INJECTING HEALTHCARE PROFESSIONAL, WHO PRESCRIBED A MEDROL DOSEPAK. APPROXIMATELY TWO WEEKS LATER, THE PT RETURNED TO THE OFFICE AND WAS TREATED WITH KEFLEX. THE FOLLOWING DAY, THE PT REPORTED "DISCHARGE" AT THE INJECTION SITE AND RETURNED TO THE OFFICE, AT WHICH POINT THE HEALTHCARE PROFESSIONAL "DRAINED MATERIAL FROM THE RIGHT CHEEK ABSCESS". THE HEALTHCARE PROFESSIONAL SAW THE PT THREE DAYS LATER AND STATED THAT THE PT "LOOKED GOOD", BUT SYMPTOMS WERE NOT FULLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642596 JUVEDERM VOLUMA XC 27G 2X1ML LMH ALLERGAN NA VB20A40143

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention VITAMIN B 12| VITAMIN D| VITAMIN B COMPLEX| CALCIUM| DEXILANT| PREVACID