BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 508540 · Received January 28, 2004

    Report

    Report Number
    2246315-2004-00010
    Event Type
    Injury
    Date Received
    January 28, 2004
    Date of Event
    December 1, 2003
    Report Date
    January 27, 2004
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INFO WAS RECEIVED IN JAN 2004 FROM A PATIENT, WITH A HISTORY OF OSTEOARTHRITIS, LOW THYROID, AN UNSPECIFIED HEART CONDITION AND OPEN-HEART SURGERY 15 YEARS AGO. THE PATIENT RECEIVED A SERIES OF THREE SYNVISC INJECTIONS, ADMINISTERED ONE WEEK APART, IN THEIR RIGHT KNEE. PATIENT DID NOT EXPERIENCE ANY ADVERSE REACTIONS WITH THE FIRST TWO SYNVISC INJECTIONS, HOWEVER WITHIN A FEW HOURS OF RECEIVING THE THIRD SYNVISC INJECTION PATIENT EXPERIENCED "SPASMS AND CRAMPS" IN THE RIGHT LEG, WHICH ARE CONSTANT AND START ABOVE THE RIGHT KNEE, GO TO THE THIGH, INTO THE GROIN AND UP THE HIP OF THEIR RIGHT SIDE. PATIENT IS HAVING DIFFICULTY SLEEPING AT NIGHT DUE TO THE SPASMS AND CRAMPS. APPROXIMATELY TWO WEEKS AGO, PATIENT WAS EVALUATED BY THEIR PHYSICIAN, WHO FELT THE SPASMS AND CRAMPS WERE DUE TO A PROBLEM WITH ELECTROLYTES. A BLOOD TEST WAS GIVEN, THE PATIENT'S BLOOD TEST REVEALED NORMAL POTASSIUM, LOW SODIUM (129) AND LOW CHLORIDE (97). DUE TO THE BLOOD TEST RESULTS, THE PHYSICIAN DECREASED THE PATIENT'S LASIX DOSAGE FROM 40MG QD TO 20MG QD AND THIER SYMPTOMS WORSENED. ONE WK AGO, QUININE SULFATE, 325 MG HS WAS INIITATED AND THEIR SYMPTOMS WORSENED. IN JAN 2004 THE PATIENT WAS ADMINISTERED A CORTISONE INJECTION (DOSAGE UNKNOWN) IN THE RIGHT KNEE. THREE DAYS LATER THE PATIENT IS SCHEDULED FOR ANOTHER BLOOD TEST TO DETERMINE IF THE BLOOD SODIUM AND CHLORIDE LEVELS HAVE IMPROVED OVER THE PAST TWO WEEKS. THE PATIENT HAS NEVER RECEIVED ANY TYPE OF VISCOSUPPLEMENTATION PRIOR TO RECEIVING SYNVISC. AT THE TIME OF THIS REPORT, THEIR SYMPTOMS HAVE NOT IMPROVED.

    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 91 YR Required Intervention