BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION UNK)

    MDR report key: 2230816 · Received August 23, 2011

    Report

    Report Number
    3005113652-2011-00065
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PT REPORTED SWELLING, REDNESS AND PAIN (IN THE UPPER RIGHT LIP) 24 HRS AFTER TREATMENT WITH JUVEDERM (UNK FORMULATION) IN UPPER LIP AND NASOLABIAL FOLDS. THE PT REPORTED THAT THE PHYSICIAN INSTRUCTED THE PT TO TAKE BENADRYL, PREDNISONE, AND KEFLEX TO TREAT THE SYMPTOMS. THE PT DECLINED TO PROVIDE THE DOCTOR'S CONTACT INFO OR PERMISSION TO CONTACT THE PHYSICIAN. 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 (VOLUME/CONCENTRATION UNK) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention THE PT WAS TAKING WELLBUTRIN