BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML

    MDR report key: 3954710 · Received July 18, 2014

    Report

    Report Number
    3005113652-2014-00332
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    March 16, 2014
    Report Date
    June 24, 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 HAVE BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT OF BRUISING, REDNESS, INFECTION, BLISTER AND INFLAMMATION 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 ONE DAY AFTER INJECTION IN AN UNSPECIFIED SITE WITH JUVEDERM VOLUMA XC, THE PATIENT DEVELOPED "REDNESS, SWELLING, AND A SMALL BLISTER" AT THE RIGHT UPPER MID CHEEK THAT LASTED FOR 3 DAYS. THREE WEEKS FOLLOWING INJECTION THE PATIENT INFORMED THE HEALTHCARE PROFESSIONAL THAT THEY WERE DEVELOPING A "BAD INFECTION" FOR WHICH THEIR GENERAL PRACTIONER HAD PRESCRIBED ANTIBIOTICS. THE INJECTING HEALTHCARE PROFESSIONAL CONFIRMED THE PATIENT DEVELOPED AN INFLAMMATORY RESPONSE. WITHIN A WEEK OF INJECTION MOST SYMPTOMS HAD RESOLVED BUT THERE WAS STILL PALPABLE BRUISING OF THE LEFT CHEEK AREA; THIS BRUISING WAS TREATED WITH MASSAGE. THREE MONTHS AFTER INJECTION, THE PATIENT HAS REPORTED THAT THE BRUISING IS STILL PRESENT AND CONTINUES TREATMENT OF ANTIBIOTICS AND CREAMS FROM THE REPORTED "INFECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423127 JUVEDERM VOLUMA WITH LIDOCAINE 1ML LMH ALLERGAN NA VB20A30323

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention 6 UNITS OF DYSPORT