BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNVISC (HYLAN G-F 20)

    MDR report key: 974924 · Received January 4, 2008

    Report

    Report Number
    2246315-2008-00002
    Event Type
    Death
    Date Received
    January 4, 2008
    Date of Event
    January 1, 2007
    Report Date
    December 12, 2007
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEATH NOS [DEATH]. COULD NOT MOVE BODY/HAD TO LIE FLAT IN BED [IMMOBILE]. REMOVAL OF FLUID FROM RIGHT KNEE [ASPIRATION JOINT]. SWELLING IN THE RIGHT KNEE/SWELLED TO TWO TIMES ITS SIZE [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 12-DEC-2007 FROM CONSUMER REGARDING A MALE KNEE PAIN PT. THE PT HAS A MEDICAL HISTORY OF KNEE PAIN, KIDNEY DISEASE WITH DIALYSIS AND HEART PROBLEMS. THE PT RECEIVED HIS FIRST DOSE OF SYNVISC IN 2007 ADMINISTERED VIA INTRA-ARTICULAR ROUTE AT A DOSE OF 2ML IN BOTH KNEES. ON AN UNK NUMBER OF DAYS AFTER STARTING SYNVISC, THE PT EXPERIENCED SWELLING IN THE RIGHT KNEE/SWELLED TO TWO TIMES ITS SIZE, COULD NOT MOVE BODY/HAD TO LIE FLAT IN BED, REMOVAL OF FLUID FROM RIGHT KNEE, AND DEATH. SYNVISC WAS LAST ADMINISTERED PRIOR TO THE REPORTED EVENT(S) EIGHT MONTHS LATER. ON AN UNK DATE, THE PT WAS HOSPITALIZED, HAD A KNEE WASHOUT PERFORMED IN THE RIGHT KNEE AND HAD "OTHER UNSPECIFIED TREATMENTS." SIX MONTHS LATER, THE PT DIED FROM AN UNK CAUSE OF DEATH. AS OF THE DATE OF RECEIPT OF THIS REPORT THE PT OUTCOME WAS DEAD. NO CONCOMITANT MEDICATIONS REPORTED. THE COMPANY ASSESSED THE RELATIONSHIP BETWEEN COULD NOT MOVE BODY/HAD TO LIE FLAT IN BED, REMOVAL OF FLUID FROM RIGHT KNEE, WASHOUT OF THE RIGHT KNEE AS POSSIBLY RELATED TO SYNVISC. THE COMPANY ASSESSED THE RELATIONSHIP BETWEEN DEATH AS UNLIKELY RELATED TO SYNVISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| H| R