BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA

    MDR report key: 2994409 · Received March 5, 2013

    Report

    Report Number
    3005113652-2013-00021
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 8, 2013
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE LABELING: (B)(4).

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AFTER INJECTION WITH JUVEDERM ULTRA AND JUVEDERM ULTRA PLUS IN THE CHEEKS, NASOLABIAL FOLDS, AND JOWLS, THE PT EXPERIENCED "SWELLING, DISCHARGE AND REDNESS OF THE SKIN." TREATMENT PERFORMED INCLUDED HYALURONIDASE INJECTIONS IN SYMPTOMATIC LOCATIONS AND PRESCRIPTION OF AN UNSPECIFIED ORAL ANTIBIOTIC. IT IS UNK IF SYMPTOMS HAVE RESOLVED AT THIS TIME. THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID # 3005113652-2012-00020 ((B)(4)). THIS MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, JUVEDERM ULTRA, ALSO A DEVICE MANUFACTURED BY ALLERGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93178 JUVEDERM ULTRA LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention JUVEDERM ULTRA PLUS INJECTION IN THE CHEEKS,| NASOLABIAL FOLDS, AND JOWLS