BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAND G-F 20) INJECTION

    MDR report key: 2989534 · Received February 28, 2013

    Report

    Report Number
    2246315-2013-00044
    Date Received
    February 28, 2013
    Date of Event
    December 11, 2012
    Report Date
    February 20, 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

    QA (QUALITY ASSURANCE) INVESTIGATION RESULT WAS REC'D 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 REVIEW 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

    ARTHRITIS [ARTHRITIS]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS REC'D ON (B)(6) 2013 (ADD'L INFO WAS REC'D ON (B)(6) 2013) 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) 2012, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION, AT A DOSE OF 2 ML, ROUTE AND FREQUENCY NOT PROVIDED, IN LEFT KNEE. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 2012, THE PT WAS ADMINISTERED WITH SECOND SYNVISC INJECTION. ON THE SAME DAY, SEVERAL HRS LATER, THE PT DEVELOPED ARTHRITIS AND SYNVISC WAS PERMANENTLY DISCONTINUED. ON (B)(6) 2012, THE PT RECOVERED FROM THE EVENT OF ARTHRITIS. IT WAS REPORTED THAT THE PT HAD NO SYMPTOM OF ARTHRITIS SINCE RECOVERY. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF ARTHRITIS WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF ARTHRITIS AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86643 SYNVISC (HYLAND G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other