BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2982581 · Received February 25, 2013

    Report

    Report Number
    2246315-2013-00041
    Date Received
    February 25, 2013
    Date of Event
    August 16, 2012
    Report Date
    February 15, 2013
    Manufacturer
    GENZYME CORPORATION (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA 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 THROUGH THE NCR PROCESS. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT SAFETY. THIS REVIEW HAS NOT INDICATED ANY SAFETY ISSUE. GENZYME BIOSURGERY WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF CORRECTIVE ACTION IS REQUIRED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    JOINT FLUID RETENTION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PATIENT, INITIALS (NOT PROVIDED), WITH GONARTHROSIS. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT INITIATED TREATMENT WITH SYNVISC INJECTION IN RIGHT KNEE AT A DOSE OF 2 ML (ROUTE AND FREQUENCY NOT PROVIDED). THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT DEVELOPED JOINT FLUID RETENTION. ON THE SAME DAY, THE TREATMENT WITH SYNVISC WAS PERMANENTLY DISCONTINUED. IT WAS REPORTED THAT THE EVENT OF JOINT FLUID RETENTION ALLEVIATED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF JOINT FLUID RETENTION WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT AS DEFINITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80926 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other