BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION UNK)

    MDR report key: 3874114 · Received May 29, 2014

    Report

    Report Number
    3005113652-2014-00214
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: 05/29/2014. FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PT DETAILS HAVE BEEN REQUESTED. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE EVENTS OF "GASTRO", SWELLING, AND TENDERNESS 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

    PT REPORTED AFTER INJECTION WITH JUVEDERM IN AN UNSPECIFIED LOCATION, THEY DEVELOPED "GASTRO". SUBSEQUENTLY, THE AREAS PREVIOUSLY INJECTED WITH JUVEDERM STARTED "PLAYING UP" AND THE PT DEVELOPED SWELLING AND TENDERNESS OF THE LEFT EYE AND TENDERNESS OF "OTHER FACIAL SPOTS." THE PT WAS TREATED WITH "ANTIBIOTICS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316877 JUVEDERM (VOLUME/CONCENTRATION UNK) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention