BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2989689 · Received February 22, 2013

    Report

    Report Number
    2246315-2013-00035
    Date Received
    February 22, 2013
    Date of Event
    April 17, 2012
    Report Date
    February 15, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2013. 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 SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED. 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. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    FLUID RETENTION IN RIGHT KNEE [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PATIENT, INITIALS UNKNOWN, WITH GONARTHROSIS. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS USE OF SYNVISC INJECTION. ON AN UNSPECIFIED DATE IN 2012, THE PATIENT INITIATED TREATMENT WITH SECOND COURSE OF SYNVISC INJECTION, 2 ML, (SECOND INJECTION) IN RIGHT KNEE (ROUTE OF ADMINISTRATION NOT PROVIDED). THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT EXPERIENCED FLUID RETENTION IN RIGHT KNEE. ON THE SAME DAY, THE TREATMENT WITH SYNVISC WAS PERMANENTLY DISCONTINUED. THE EVENT OF RIGHT KNEE EFFUSION WAS NOT YET RECOVERED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF WAS PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE CAUSAL RELATIONSHIP BETWEEN SYNVISC AND THE EVENT AS DEFINITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77264 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other