BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA XC (2 X 0.4 ML)

    MDR report key: 2003594 · Received February 22, 2011

    Report

    Report Number
    3005113652-2011-00007
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 28, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    COMPANY REP REPORTED ON BEHALF OF A PHYSICIAN THAT A PT PRESENTED WITH NECROSIS IN THE LEFT SIDE OF THE GLABELLA AFTER TREATMENT WITH JUVEDERM ULTRA XC (.4 ML) IN THE GLABELLA. THE PT EXPERIENCED BLANCHING AT THE INJECTION SITE AND THE INJECTOR MASSAGED THE AREA AND APPLIED HEAT AND COLD. THE PT REPORTED THE NEXT DAY THAT THE BRIDGE OF THE NOSE WAS SWOLLEN. THE PT WAS SEEN BY A PLASTIC SURGEON WHO PRESCRIBED AN ANTIBIOTIC (POSSIBLY CIPRO) AND THOUGHT IT MIGHT BE AN INFECTION. ON THE THIRD DAY AFTER INJECTION THE GLABELLA WAS PINK AND WARM. THE PLASTIC SURGEON SQUEEZED SOME PUS OUT OF THE GLABELLA AT TWO DIFFERENT APPOINTMENTS. AFTER THE SECOND APPOINTMENT THE PLASTIC SURGEON OBSERVED SUPERFICIAL NECROSIS AT THE GLABELLA. THE PT THEN SAW A DERMATOLOGIST WHO THOUGHT THAT THE MASSAGE, HEAT AND COLD, AND HYALURONIDASE WOULD BE APPROPRIATE TREATMENT BUT HYALURONIDASE WAS NOT PRESCRIBED TO THE PT. THE PT IS STILL SEEING THE DERMATOLOGIST AND IS BEING TREATED WITH LYMPHATIC DRAINAGE. THE ANTIBIOTIC (CIPRO) WAS PRESCRIBED BOTH TO HASTEN THE RESOLUTION OF THE PT'S SYMPTOMS AND TO PREVENT WORSENING OF THE SYMPTOMS THAT MAY LEAD TO PERMANENT DAMAGE. THE GLABELLA IS HEALING NICELY. THE PT IS STILL EXPERIENCING REDNESS AND AN INDENTATION AT THE LEFT SIDE OF THE GLABELLA AT THE INJECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA XC (2 X 0.4 ML) LMH ALLERGAN NA H24L589545

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention