BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1611827 · Received February 12, 2010

    Report

    Report Number
    2246315-2010-00026
    Event Type
    Other
    Date Received
    February 12, 2010
    Report Date
    February 4, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# S0911, WITH EXPIRATION DATE 04/2012 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    RIGHT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 04-FEB-2010, FROM HEALTHCARE PROVIDER REGARDING A (B)(6) MALE PT, WITH A HISTORY OF OSTEOARTHRITIS, INITIALS (B)(6), WHO EXPERIENCED RIGHT KNEE EFFUSION AFTER RECEIVING SYNVISC. THE PT RECEIVED INJECTIONS OF SYNVISC INTO BOTH KNEES ON (B)(6) 2009. THE PT REPORTED THAT HE HAD A RIGHT KNEE EFFUSION AFTER RECEIVING SYNVISC AND WAS TREATED WITH A MEDROL DOSEPAK. THE HCP REPORTED THAT THE RELATIONSHIP OF THE PT'S EVENT WITH SYNVISC WAS DEFINITE. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK. THE LOT NUMBER WAS REPORTED TO BE S0911 WITH AN EXPIRATION DATE OF APRIL 2012. ADDITIONAL INFO WAS RECEIVED ON 11-FEB-2010, IN THE FORM OF QA RESULTS. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT # S0911, WITH EXPIRATION DATE 04/2012 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MFR'S COMMENTS: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK S0911

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention