BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION UNK)

    MDR report key: 1022605 · Received April 1, 2008

    Report

    Report Number
    3005113652-2008-00021
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 6, 2008
    Manufacturer
    CORNEAL
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AFTER TREATMENT IN THE NASOLABIAL FOLDS AND THE ORAL COMMISSURES WITH JUVEDERM, THE PT EXPERIENCED AN ALLERGIC REACTION. THE PT HAS A HISTORY OF ALLERGIES AND ATE A SANDWICH CONTAINING FOODS THAT THE PT IS ALLERGIC TO AFTER THE TREATMENT WITH JUVEDERM. THE PT DOES NOT KNOW IF THERE IS AN ALLERGIC REACTION TO JUVEDERM OR TO THE SANDWICH EATEN. THE PT NOTES A FEW HRS AFTER TREATMENT THERE WAS ITCHING, SWELLING, REDNESS, AND BUMPS AROUND THE EYES. THE PHYSICIAN PRESCRIBED PREDNISONE. THE PT DECLINED TO PROVIDE THE PHYSICIAN CONTACT. ALLERGAN IS UNABLE AT THIS TIME TO FOLLOW UP WITH THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM (VOLUME/CONCENTRATION UNK) JUVEDERM LMH CORNEAL NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SUBLINGUAL SWALLOW DROPS BY ANTIGEN LAB.