BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2222709 · Received July 28, 2011

    Report

    Report Number
    2246315-2011-00190
    Date Received
    July 28, 2011
    Report Date
    July 18, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011. EVALUATION SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED THEREFORE; A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS.

    Description of Event or Problem · 1

    JOINT INFECTION [ARTHRITIS INFECTIVE]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011, FROM A PHYSICIAN REGARDING A PATIENT, AGE, GENDER AND INITIALS NOT PROVIDED. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. THE PATIENT RECEIVED SYNVISC (THE DEVICE WAS NOT VERY CLEAR FROM THE REPORT) ON AN UNKNOWN DATE, LOCATION NOT PROVIDED AS WELL. THE PATIENT EXPERIENCED JOINT INFECTION. THE HCP REPORTED THAT HE HAD SEEN SUCH EVENTS IN TWO CASES, THIS REPORT BEING THE FIRST CASE. NO OTHER DETAILS ARE AVAILABLE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other