BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUVEDERM ULTRA

    MDR report key: 1000948 · Received February 20, 2008

    Report

    Report Number
    3005113652-2008-00013
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 16, 2008
    Report Date
    January 22, 2008
    Manufacturer
    CORNEAL
    Product Code
    LMH
    PMA / PMN Number
    P050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MED WATCH SENT TO FDA ON 02/20/2008. DEVICE EVAL SUMMARY: THE DOCUMENTARY RESEARCH IN THE BATCH FILE SHOWS THAT NO ELEMENT COULD EXPLAIN THIS REACTION: ALL THE MFG STEPS AND ALL THE PHYSICOCHEMICAL (EXTRUSION FORCE) AND MICROBIOLOGICAL RESULTS (ENDOTOXINS, BIOBURDEN, STERILITY TEST, STERILIZATION CYCLE) ARE REGISTERED AS CONFORMING TO THE SPECIFICATIONS. IN CONCLUSION, AS ALL THE ANALYSIS RESULTS OF THE BATCH ARE CONFORMING.

    Description of Event or Problem · 1

    AFTER TREATMENT WITH JUVEDERM ULTRA ON THE PT'S LEFT CHEEK BLANCHING WAS OBSERVED AND NOTED TO HAVE QUICKLY PINKED UP LEAVING ONLY A SMALL BRUISE. FIVE DAYS AFTER TREATMENT THE PT PRESENTED WITH REDNESS AND SWELLING AT THE TREATMENT SITE ALONG WITH DIFFICULTY BREATHING AND SWALLOWING . TREATMENT WAS GIVEN TO THE PT IN THE ER BY A PHYSICIAN OTHER THAN THE INITIAL TREATING PHYSICIAN. THE PT WAS TREATED WITH AN EPINEPHRINE SHOT, ORAL ANTIHISTAMINES, MEDROL DOSEPAK, RANITIDINE, ZYRTEC, PREDNISONE, XANAX, AND AN ALBUTEROL NEBULIZER. DIAGNOSIS ALLERGIC REACTION, ETIOLOGY UNK. THE PT, A CAT OWNER, HAS SINCE BEEN DIAGNOSED WITH AN ALLERGY TO CATS PER ONGOING ALLERGY TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUVEDERM ULTRA JUVEDERM LMH CORNEAL NA HV24243590

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention AMINOS