BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK JUVEDERM VOLUMA

    MDR report key: 4213037 · Received October 24, 2014

    Report

    Report Number
    3005113652-2014-00577
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P110033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 EDEMA AND RHINITIS 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

    HEALTHCARE PROFESSIONAL REPORTED APPROX 4 WEEKS AFTER INJECTION WITH UNSPECIFIED JUVEDERM VOLUMA THE PT DEVELOPED EDEMA AND RHINITIS AFTER VISITING A "HAMMAN" (STEAM ROOM). PT WAS TREATED WITH SOLUPRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678599 UNK JUVEDERM VOLUMA LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention