BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM VOLUMA WITH LIDOCAINE 1ML

    MDR report key: 3874091 · Received May 29, 2014

    Report

    Report Number
    3005113652-2014-00241
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    March 30, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE EVENTS OF PUS, PAIN, AND REDNESS ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLY CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED 24 HOURS AFTER INJECTION IN THE "DEPRESSION OF THE NOSE IN THE RIGHT SIDE (POST SURGICAL)" WITH JUVEDERM VOLUMA WITH LIDOCAINE, THE PT DEVELOPED "ACUTE PAIN AND REDNESS IN THE INJECTION SITE." AFTER 48 HRS, "THE REDNESS COVERED ALL RIGHT SIDE OF THE NOSE WITH POINTS OF PUS." PT WAS TREATED WITH KEFLEX, DALACIN, AND NIMESULIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317070 JUVEDERM VOLUMA WITH LIDOCAINE 1ML LMH ALLERGAN NA VB20A30405

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention