BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION 6/ML

    MDR report key: 1517180 · Received October 27, 2009

    Report

    Report Number
    2246315-2009-00210
    Date Received
    October 27, 2009
    Date of Event
    January 1, 2009
    Report Date
    October 19, 2009
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY - THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# R0905, 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

    PSEUDOSEPTIC REACTION IN RIGHT KNEE (JOINT INFLAMMATION) [ARTHRITIS]; KNEE EFFUSION [JOINT EFFUSION] CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2009 FROM A HEALTH CARE PROVIDER REGARDING A (B)(6) FEMALE PT WITH A HISTORY OF OSTEOARTHRITIS OF THE KNEE, INITIALS (B)(6), WHO EXPERIENCED PSEUDOSEPTIC REACTION AFTER RECEIVING SYNVISC-ONE. THE PT RECEIVED AN INJECTION SYNVISC-ONE INTO HER RIGHT KNEE ON (B)(6) 2009. THE HCP REPORTED THAT THE PT HAS A PSEUDOSEPTIC REACTION AFTER RECEIVING SYNVISC-ONE IN HER RIGHT KNEE. THE PT WENT TO THE EMERGENCY ROOM DUE TO THE ADVERSE REACTION AND HER RIGHT KNEE WAS ASPIRATED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK. THE QA RESULTS FOR THIS CASE WERE RECEIVED ON (B)(6) 2009. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# R0905, WITH EXPIRATION DATE 04/2012 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MANUFACTURES COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC ONE IS NOT AFFECTED BY THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC ONE (HYLAN G-F 20) INJECTION 6/ML INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK R0905

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other