BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1

    MDR report key: 3913161 · Received June 11, 2014

    Report

    Report Number
    3005113652-2014-00287
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADD'L INFO IS AVAILABLE AT THIS TIME. THE EVENTS OF "HYPEREMIA, INFLAMMATION, EDEMA, INDURATION, AND SLIGHT HYPERTHERMIA" 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 28 DAYS AFTER INJECTION WITH JUVEDERM VOLUMA WITH LIDOCAINE IN THE JOWL AND ZYGOMATIC AREA, THE PT DEVELOPED HYPEREMIA OF THE RIGHT JOWL/CHEEK. UPON EXAMINATION, THE HEALTHCARE PROFESSIONAL OBSERVED HYPEREMIA, INFLAMMATION, EDEMA, INDURATION, AND SLIGHT HYPERTHERMIA. PT WAS PRESCRIBED "AMOXICLAV", "SUMAMED" ,"LYNEX", "HYALURONIDAZA INJECTIONS", "POLYXIDONIUM", A "GENTAMICIN + DIPROSPAN INJECTION", AND A "GENTAMICIN + FLUOROURATSIL INJECTION." AN ULTRASOUND WAS PERFORMED AFTER "RELIEF SYMPTOMS" NOTING NO "SIGNS OF INFLAMMATION FOUND IN THE RIGHT CHEEK REGION; THE SUBCUTANEOUS FAT PRODUCT LOCALIZED." SYMPTOMS RESOLVED A MONTH AND A HALF AFTER INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343676 JUVEDERM VOLUMA WITH LIDOCAINE 1ML SKU1 LMH ALLERGAN NA VB20A30273

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention