BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2524920 · Received April 5, 2012

    Report

    Report Number
    2246315-2012-00086
    Date Received
    April 5, 2012
    Date of Event
    November 10, 2011
    Report Date
    March 30, 2011
    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

    MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT. THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON 02-APR-2012. EVAL 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 SPEC CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPEC 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.

    Description of Event or Problem · 1

    ARTHRITIS [ARTHRITIS]. JOINT FLUID ASPIRED [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON 30-MAR-2012 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6), WITH GONARTHROSIS. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2011, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN G F 20) INJECTION, 2 ML, IN AN UNSPECIFIED JOINT. THE SYNVISC LOT NUMBER WAS NOT PROVIDED. ON (B)(6) 2011, THE PT RECEIVED SECOND INJECTION OF SYNVISC. ON (B)(6) 2011, THE PT RECEIVED THIRD INJECTION OF SYNVISC AND DEVELOPED ARTHRITIS. ON (B)(6) 2011, 60 CC OF JOINT FLUID WAS ASPIRATED. THE EVENT OF ARTHRITIS WAS ASSESSED AS MEDICALLY SIGNIFICANT. ON (B)(6) 2011, THE EVENT OF ARTHRITIS RECOVERED. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF "JOINT FLUID ASPIRED" WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS OF ARTHRITIS AND "JOINT FLUID ASPIRED" WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF ARTHRITIS AS DEFINITE. THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF "JOINT FLUID ASPIRED" WAS NOT PROVIDED BY THE REPORTING PHYSICIAN.

    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 51 YR Other