BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1289663 · Received December 9, 2008

    Report

    Report Number
    2246315-2008-00176
    Event Type
    Other
    Date Received
    December 9, 2008
    Report Date
    December 2, 2008
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT LOT # 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 BIOSURGERY WILL CONTINUE TO MONITOR COMPLAINTS.

    Description of Event or Problem · 1

    SWELLING IN KNEE [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 02-DEC-2008 FROM A COMPANY REP REGARDING A PT (UNK INITIALS, GENDER AND AGE). WITH A HISTORY OF ARTHRITIS, WHO EXPERIENCED SWELLING IN THE AFFECTED KNEE AFTER STARTING SYNVISC. THE PT RECEIVED A SERIES OF SYNVISC INJECTIONS INTO AN UNSPECIFIED KNEE ON UNSPECIFIED DATES. THE PT EXPERIENCED SWELLING IN THE AFFECTED KNEE ON THE SECOND INJECTION. THE PT WAS TREATED WITH STEROIDS. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK.

    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 UNK Required Intervention