BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2989692 · Received February 22, 2013

    Report

    Report Number
    2246315-2013-00036
    Date Received
    February 22, 2013
    Date of Event
    October 16, 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 SUMMARY WAS RECEIVED ON (B)(4) 2013. 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 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. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    FLUID RETENTION [FLUID RETENTION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PT, INITIALS UNK WITH GONARTHROSIS. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS TWO COURSES OF SYNVISC. ON AN UNSPECIFIED DATE, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION, 2 ML OF THE THIRD COURSE (FREQUENCY NOT PROVIDED), INTO THE RIGHT KNEE. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 2012, THE PT EXPERIENCED FLUID RETENTION. ON THE SAME DAY, THE TREATMENT WITH SYNVISC WAS PERMANENTLY DISCONTINUED. THE PT HAD NOT YET RECOVERED FROM THE EVENT OF FLUID RETENTION. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS NOT PROVIDED. THE REPORTER ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF FLUID RETENTION AS DEFINITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77267 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other