BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 1852453 · Received September 30, 2010

    Report

    Report Number
    2246315-2010-00199
    Event Type
    Injury
    Date Received
    September 30, 2010
    Report Date
    September 22, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 CONFORMANCE TO SPECIFICATIONS 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 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

    SEVERE EFFUSION [EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 22-SEP-2010 FROM A HEALTH CARE PROVIDER, VIA A COMPANY REPRESENTATIVE, REGARDING A PT. THE PT HAD AN UNK HISTORY. THE PT EXPERIENCED SEVERE EFFUSION AFTER RECEIVING SYNVISC-ONE. THE PT RECEIVED A SYNVISC-ONE INJECTION IN AN UNSPECIFIED LOCATION ON AN UNSPECIFIED DATE. THE HCP REPORTED THE PT EXPERIENCED SEVERE EFFUSION, WHICH LEAD TO THE PT'S HOSPITALIZATION, FOLLOWING SYNVISC-ONE INJECTION. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK. (B)(4). ADDITIONAL INFO WAS RECEIVED ON 24-SEP-2010 IN THE FORM OF QA RESULTS. 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 CONFORMANCE TO SPECIFICATIONS 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 QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS. THE BENEFIT-RISK RELATIONSHIP OF SYNVISC ONE IS NOT AFFECTED BY THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization