BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTA PLUS XC/ LIDO (VOLUME UNKNOWN)

    MDR report key: 3192725 · Received June 24, 2013

    Report

    Report Number
    3005113652-2013-00080
    Event Type
    Injury
    Date Received
    June 24, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 27, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS TO FOLLOW UP WITH THE INJECTING PHYSICIANS HAVE BEEN UNSUCCESSFUL; THEREFORE, INFORMATION SUCH AS THE DEVICE LOT NUMBER IS AVAILABLE AT THIS TIME. DEVICE LABELING: UNDESIRABLE EFFECTS - THE PATIENT MUST BE INFORMED THAT THERE ARE POTENTIAL SIDE EFFECTS LINKED TO THIS PROCEDURE, WHICH CAN BE EITHER IMMEDIATE OR DELAYED. THESE INCLUDE, BUT ARE NOT LIMITED TO: INFLAMMATORY REACTIONS (REDNESS, OEDEMA, ERYTHEMA, ETC.) WHICH MAY BE ASSOCIATED WITH ITCHING OR PAIN ON PRESSURE OR BOTH, OCCURRING AFTER THE INJECTION. ANY OTHER UNDESIRABLE SIDE EFFECTS ASSOCIATED WITH INJECTION OF JUVEDERM ULTRA PLUS XC MUST BE REPORTED TO THE DISTRIBUTOR AND/OR TO THE MFR.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED 2-3 DAYS AFTER INJECTION WITH JUVEDERM ULTRA PLUS XC IN THE NASOLABIAL FOLDS USING AN ASEPTIC TECHNIQUE BY 2 DIFFERENT INJECTORS, PATIENT DEVELOPED "LOCALIZED TENDERNESS AND THROBBING". PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND THE REPORTED SYMPTOMS RESOLVED "QUICKLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285179 JUVEDERM ULTA PLUS XC/ LIDO (VOLUME UNKNOWN) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention