BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM FORMA ROW

    MDR report key: 1716620 · Received June 9, 2010

    Report

    Report Number
    3005113652-2010-00045
    Event Type
    Injury
    Date Received
    June 9, 2010
    Date of Event
    January 27, 2010
    Report Date
    March 19, 2010
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED AFTER TREATMENT WITH JUVEDERM FORMA FOR FACIAL LIPODYSTROPHY, THE PT EXPERIENCED ITCHING, LOCAL PAIN, FACIAL EDEMA, AND NAUSEA. SYMPTOMS OCCURRED THE SAME DAY OF TREATMENT. THE MEDICAL PRACTITIONER BELIEVES THE EVENT IS PRODUCT RELATED. THE PT DOES NOT HAVE A HISTORY OF ALLERGIES, AUTOIMMUNE DISEASE, DERMAL PROBLEMS, STREPTOCOCCAL DISEASE, OR HYPERTROPHIC SCARS. THE PT HAS RECEIVED DERMAL FILLER (PERLANE) IN THE PAST, AND WAS NOT TAKING ANY THERAPIES CONCOMITANTLY. TREATMENT OF THE SYMPTOMS INCLUDED CORTICOID 60 MG A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM FORMA ROW LMH ALLERGAN NA IN30497951

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention