BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA PLUS XC TSK US

    MDR report key: 2130632 · Received June 14, 2011

    Report

    Report Number
    3005113652-2011-00035
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    February 9, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: (B)(4) 2011.

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THAT AFTER TREATMENT IN THE NASOLABIAL FOLDS WITH "A HALF SYRINGE" OF JUVEDERM ULTRA PLUS XC "2 OR 3 DAYS LATER" THE PT DEVELOPED AN "ALLERGIC REACTION" WHICH MANIFESTED AS "ERYTHEMA BLISTERING, AND PAIN" IN THE NASOLABIAL FOLDS, SIDE OF NOSE, AND CHEEKS. THE PT WENT TO AN URGENT CARE FACILITY WHO THOUGHT THE PT MAY HAVE HAD A (B)(6) INFECTION AND INJECTED THE PT WITH ANTIBIOTICS. FOUR DAYS LATER, THE PT WENT TO ANOTHER DOCTOR WHO CULTURED THE INFECTION, BUT IT DID NOT GROW AND COULD NOT BE DIAGNOSED. THE REPORTING PHYSICIAN DID NOT PRESCRIBE THE TREATMENTS, SO IT IS CURRENTLY UNK IF TREATMENT WAS TO HASTEN THE RESOLUTION OF SYMPTOMS OR IF IT WAS PRESCRIBED TO PREVENT THE WORSENING OF SYMPTOMS WHICH COULD HAVE LEAD TO PERMANENT DAMAGE. THIS EVENT IS BEING REPORTED BECAUSE ALLERGAN'S APPROACH TO COMPLIANCE IS TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA PLUS XC TSK US LMH ALLERGAN NA H30L601772

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention