BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK JUVEDERM VOLUMA

    MDR report key: 3810016 · Received May 1, 2014

    Report

    Report Number
    3005113652-2014-00203
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    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 NODULES IS A PHYSIOLOGICAL COMPLICATION 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 APPROXIMATELY 3-4 MONTHS AFTER INJECTION IN THE HANDS WITH UNSPECIFIED JUVEDERM VOLUMA, THE PATIENT DEVELOPED NODULES AT THE INJECTION SITE. PATIENT WAS TREATED WITH "DIPROSPAN". THE NODULES "DISAPPEAR AND APPEAR" HOWEVER, "CURRENTLY PATIENT IS WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262111 UNK JUVEDERM VOLUMA LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention