BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM (VOLUME/CONCENTRATION UNKNOWN)

    MDR report key: 1062088 · Received June 17, 2008

    Report

    Report Number
    3005113652-2008-00036
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 10, 2008
    Manufacturer
    PRINGY
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABOUT TEN DAYS AFTER TREATMENT WITH JUVEDERM IN THE LIPS, THE PATIENT'S HUSBAND STATED THAT THE PATIENT EXPERIENCED SYMPTOMS OF HIVES ON HER THIGHS, ABDOMEN, CHEST, AND UPPER ARMS AND EDEMA IN THE LIPS. THE PATIENT WAS GIVEN INTERVENTION BY URGENT CARE WITH SOLUMEDROL AND ANTIHISTAMINES THROUGH AN IV AND A PRESCRIPTION OF PREDNISONE DOSEPAK, WHICH CAUSED THE SYMPTOMS TO RESOLVE. THE SYMPTOMS ALSO OCCURRED ON OTHER OCCASIONS AFTER THE FIRST SYMPTOMS RESOLVED AND THE PATIENT EXPERIENCED HIVES ON THE UPPER BODY AND ON THE HEAD AND EDEMA IN THE LIPS. AN UNIDENTIFIED DERMATOLOGIST PRESCRIBED MORE POTENT ANTIHISTAMINE. ALLERGAN'S ATTEMPTS TO CONTACT THE PATIENT BY PHONE IN ORDER TO GATHER FURTHER INFORMATION AND OBTAIN PERMISSION TO CONTACT THE TREATING PHYSICIAN HAVE BEEN UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention YES