BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS

    MDR report key: 3040129 · Received April 3, 2013

    Report

    Report Number
    3005113652-2013-00035
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 8, 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

    MEDWATCH SENT TO FDA ON (B)(4) 2013. ALLERGAN HAS REQUESTED FURTHER INFORMATION REGARDING THIS EVENT SUCH AS THE LOT NUMBER OF THE DEVICE. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. DEVICE LABELING: UNDESIRABLE EFFECTS: PRACTITIONERS MUST INFORM THE PATIENT THAT THERE ARE POTENTIAL SIDE EFFECTS ASSOCIATED WITH IMPLANTATION OF THIS DEVICE, WHICH MAY OCCUR IMMEDIATELY OR MAY BE DELAYED. THESE INCLUDE (NON-EXHAUSTIVE LIST): INFLAMMATORY REACTIONS (E.G. REDNESS, OEDEMA, ERYTHEMA) WHICH MAY BE ASSOCIATED WITH ITCHING, PAIN ON PRESSURE, OCCURRING AFTER THE INJECTION. THESE REACTIONS MAY LAST FOR A WEEK.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL NOTED AFTER PATIENT WAS INJECTED IN THE NASOLABIAL FOLDS WITH 1ML OF JUVEDERM ULTRA PLUS, PATIENT DEVELOPED ITCHING AND REDNESS EXTENDING FROM THE NASOLABIAL FOLDS TO THE GLABELLAR AREA ONE DAY LATER. PATIENT WAS TREATED WITH "CEFLEX".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136831 JUVEDERM ULTRA PLUS LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention