BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 510930 · Received February 9, 2004

    Report

    Report Number
    2246315-2004-00017
    Event Type
    Injury
    Date Received
    February 9, 2004
    Date of Event
    January 23, 2004
    Report Date
    February 9, 2004
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED IN JAN 2004 FROM A PT WITH A HISTORY OF NO CARTILAGE IN THEIR RIGHT KNEE, A TWISTED RIGHT ANKLE AT BIRTH, ARTHRITIS AND BONE SPURS IN THE RIGHT ANKLE, RESTLESS LEG SYNDROME, SPASTIC BOWEL, STOMACH ULCERS, AND SLEEP APNEA THAT REQUIRES THE USE OF A CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE. THE PT FELL ON THEIR RIGHT KNEE IN OCT 2003 (DETAILS NOT PROVIDED). THE PT RECEIVED TWO SYNVISC INJECTIONS TO THE RIGHT KNEE TWICE WITHIN A WEEK, RESPECTIVELY. THE PT REPORTED THAT THE FIRST INJECTION WAS ADMINISTERED THROUGH THE INSIDE OF THEIR RIGHT KNEE WITHOUT PROBLEMS, AND THE SECOND INJECTION WAS ADMINISTERED THROUGH THE FRONT OF THE RIGHT KNEE AND WAS "PAINFUL AND PT FELT IT IN THE BACK OF THE KNEE." IN 2004, THE PT BEGAN TO EXPERIENCE SWELLING OF THEIR RIGHT LOWER LEG AND ANKLE. TWO DAYS LATER, THE PT'S RIGHT LOWER LEG AND ANKLE WERE VERY PAINFUL AND PT COULD BARELY WALK. TWO DAYS LATER, SYNOVIAL FLUID WAS ASPIRATED (VOLUME NOT PROVIDED) FROM THE PT'S ANKLE, AND THE FLUID "LOOKED LIKE DIRTY MILK," AND WAS SENT FOR CULTURE (NO RESULTS PROVIDED). THE PT WAS TREATED WITH A CORTISONE INJECTION TO THE RIGHT ANKLE THE SAME DAY AND IS MUCH IMPROVED AT THE TIME OF THIS REPORT. AT THE TIME OF THIS REPORT, THE PT STATED THAT "SYNVISC IS WORKING BECAUSE ABOUT 75% OF THE PAIN PT HAD BEFORE THE TREATMENT IS GONE." THE REVEIW OF SYNVISC PRODUCT RELEASE DATA FOR BOTH FACILITIES DID NOT INDICATE TRENDS THAT COULD BE ASSOCIATED TO ANY PRODUCT COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC HYLAN G-F 20 MOZ GENZYME CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention