BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3201671 · Received June 28, 2013

    Report

    Report Number
    2246315-2013-00378
    Event Type
    Injury
    Date Received
    June 28, 2013
    Report Date
    June 19, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2013. 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. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    RIGHT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013, FROM AN OFFICE MANAGER REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6). THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION, (ROUTE AND DOSAGE REGIMEN NOT PROVIDED) IN RIGHT KNEE. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT RECEIVED HER SECOND INJECTION IN RIGHT KNEE. IT WAS REPORTED THAT THE PT WENT TO THE EMERGENCY ROOM AND WAS ADMITTED TO THE HOSP. IT WAS REPORTED THAT HER KNEE WAS TAPPED (KNEE EFFUSION) AND LABS WERE DRAWN. IT WAS ALSO REPORTED THAT HER LABS WERE NORMAL. THE OUTCOME FOR THE JOINT EFFUSION WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT WAS NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295492 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R