BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1461952 · Received September 1, 2009

    Report

    Report Number
    2246315-2009-00156
    Date Received
    September 1, 2009
    Report Date
    August 20, 2009
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY - THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT #X0719 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. AS OF (B)(4) 2009, THERE ARE TWO COMPLAINTS ON FILE FOR THIS LOT INCLUDING THIS COMPLAINT, BOTH WERE ADVERSE EVENTS. GENZYME BIOSURGERY WILL CONTINUE TO MONITOR COMPLAINTS ACCORDING TO THE SOP "PRODUCT COMPLAINT HANDLING" TO DETERMINE IF CORRECTIVE ACTION WILL BE NEEDED.

    Description of Event or Problem · 1

    KNEE EFFUSION (BOTH KNEES) [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2009 FROM A PHYSICIAN REGARDING A (B)(6) MALE, INITIALS (B)(6), WITH MEDICAL HISTORY OF CHONDROMALACIA IN BOTH KNEES. THE PATIENT RECEIVED 3 SYNVISC INJECTIONS IN BOTH KNEES, THE FIRST BEING ADMINISTERED ON (B)(6) 2009 AND THE LAST ON (B)(6) 2009. ON (B)(6) 2009, THE PATIENT EXPERIENCED STRONG KNEE EFFUSION IN BOTH KNEES. KNEE PUNCTURE WAS PERFORMED AND THE RESULT SHOWED SLIGHTLY OPAQUE COLORED FLUID WITH NO SIGNS OF INFECTION. TOTAL AMOUNT OF FLUID TAKEN PER KNEE WAS 125 ML. THE PHYSICIAN ASSESSED THE SEVERITY OF THE EVENT AS SEVERE AND ASSESSED THE EVENT AS MEDICALLY SIGNIFICANT. THE RELATIONSHIP BETWEEN THE EVENT AND USE OF SYNVISC WAS ASSESSED AS DEFINITE. AT THE TIME OF THIS REPORT, THE PATIENT HAD NOT RECOVERED. PLEASE REFER TO (B)(4) FOR OTHER EVENTS REPORTED BY HIS PHYSICIAN. ON (B)(4) 2009, WE RECEIVED THE INVESTIGATIONAL SUMMARY WITH THE FOLLOWING INFORMATION: THE PRODUCT AND QUALITY CONTROL DOCUMENTATION FOR LOT #X0719 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. AS OF (B)(4) 2009, THERE ARE TWO COMPLAINTS ON FILE FOR THIS LOT INCLUDING THIS COMPLAINT, BOTH WERE ADVERSE EVENTS. GENZYME BIOSURGERY WILL CONTINUE TO MONITOR COMPLAINTS ACCORDING TO THE SOP "PRODUCT COMPLAINT HANDLING" TO DETERMINE IF CORRECTIVE ACTION WILL BE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJECTION VISCOSUPPLEMENT MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK X0719

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR