BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION UNK)

    MDR report key: 1153077 · Received September 8, 2008

    Report

    Report Number
    3005113652-2008-00056
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 09/08/2008.

    Description of Event or Problem · 1

    ABOUT THREE WEEKS AFTER TREATMENT IN THE NASOLABIAL FOLDS WITH JUVEDERM (VOLUME/CONCENTRATION UNK) THE PT EXPERIENCED A SORE, RED AND RAW THROAT. THE PT STATED THAT THE PHYSICIAN DIAGNOSED AN ALLERGIC REACTION AND PRESCRIBED CLARINEX. THE PT EXPERIENCED AN ALLERGIC REACTION TO CLARINEX AND STATES THE PHYSICIAN THEN PRESCRIBED PENICILLIN. THE PT WENT TO HER PRIMARY CARE PHYSICIAN WHO DID A THROAT CULTURE. THE PT IS TAKING NO CONCOMITANT THERAPIES AND HAD NO KNOWN ALLERGIES UNTIL THE REACTION TO CLARINEX. THE PT REQUESTED THAT THE PHYSICIANS NOT BE CONTACTED. 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 (VOLUME/CONCENTRATION UNK) JUVEDERM LMH PRINGY NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention