BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA

    MDR report key: 3834586 · Received May 2, 2014

    Report

    Report Number
    3005113652-2014-00163
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 7, 2014
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADD'L INFO IS AVAILABLE AT THIS TIME. THE EVENT OF NECROSIS 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 AFTER INJECTION WITH JUVEDERM ULTRA IN THE GLABELLA, THE PT DEVELOPED NECROSIS THE SAME DAY. THE PT DID NOT REPORT THEIR SYMPTOM TO THE HEALTHCARE PROFESSIONAL UNTIL THREE DAYS AFTER INJECTION, AT WHICH POINT THEY WERE TREATED WITH HYALURONIDASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264496 JUVEDERM ULTRA LMH ALLERGAN NA HV24A30339

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention