BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 569161 · Received January 31, 2005

    Report

    Report Number
    2246315-2005-00009
    Event Type
    Injury
    Date Received
    January 31, 2005
    Date of Event
    October 30, 2004
    Report Date
    January 28, 2005
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RIGHT ANKLE INFECTION (SWELLING, REDNESS, PAIN) [ANKLE], UNABLE TO WALK (COULD NOT BEAR WEIGHT) [ANKLE]. INFO WAS RECEIVED IN NOV. 2004 FROM A MEDICAL ASSISTANT REGARDING A PT, WITH A MEDICAL HISTORY OF OSTEOCHONDRITIS AND RIGHT ANKLE SCOPED TWO WEEKS PRIOR TO INJECTION, WHO EXPERIENECED RIGHT ANKLE SWELLING, REDNESS AND PAIN, AND UNABLE TO WALK (COULD NOT BEAR WEIGHT). THE PT BEGAN A TREATMENT WITH SYNVISC IN 2004. THE PT RECEIVED ONE SYNVISC INJECTION IN THE RIGHT ANKLE IN 2004. THE DAY FOLLOWING THE FIRST INJECTION THE PT FELT FINE BUT OVER THE WEEKEND THE PT DEVELOPED A LOT OF SWELLING, REDNESS AND PAIN, AND WAS UNABLE TO WALK (COULD NOT BEAR WEIGHT). ON THE 4TH DAY THE PT WAS SEEN BY THE PHYSICIAN AND IN 2 DAYS LATER THE ANKLE WAS SCOPED. THE CULTURE DID NOT INDICATE ANY INFECTION; SHOWED WHITE BLOOD CELLS BUT NO BACTERIA (CULTURE WAS NEGATIVE). THE REACTION WAS LIMITED TO AREA OF INJECTION. THE PHYSICIAN PRESCRIBED TYLENOL #3 AND CELEBREX FOR PAIN. AT THE TIME OF THIS REPORT, THE PT WAS IMPROVING BUT CONTINUED TO USE A CANE FOR WALKING. ADD'L INFO WAS RECEIVED IN 16 DAYS LATER FROM THE PHYSICIAN. THE PT WAS INTERESTED IN TRYING SYNVISC PRIOR TO HAVING A RIGHT ANKLE FUSION (PT HAD A "BAD" ANKLE AND WAS HEADING FOR AN ANKLE FUSION). A STERILE PREP WAS DONE PRIOR TO THE SYNVISC INJECTION. THREE TO FOUR DAYS AFTER THE INJECTION, THE PT HAD A REACTION TO SYNVISC WITH RED STREAKING. THE PHYSICIAN FELT THIS WAS MOST DEFINITELY AN INFECTION AND TREATED THEM ON AN OUTPATIENT BASIS WITH ARTHROSCOPIC PROCEDURE ON THE PREVIOUS TIME. THE ANKLE WAS WASHED AND CLEANED OUT, THEN FLUSHED WITH IV ANTIBIOTICS. THE PT CONTINUED TREATMENT WITH ORAL ANTIBIOTICS. THE PT WAS SEEN IN 2 WEEKS LATER AND WAS "DOING FINE". AT THE TIME OF THIS REPORT, THE PT HAD RECOVERED WITHOUT SEQUELAE. SYNVISC IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS,( E.G. ACETAMINOPHEN). SYNVISC IS ALSO INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE HIP IN OTHER COUNTRIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC HYLAN G-F 20 MOZ GENZYME CORPORATION NA U0413

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R