BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1202915 · Received October 17, 2008

    Report

    Report Number
    2246315-2008-00151
    Event Type
    Other
    Date Received
    October 17, 2008
    Date of Event
    October 9, 2006
    Report Date
    July 7, 2008
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    KNEE SWELLING [JOINT SWELLING], KNEE PAIN [ARTHRALGIA]. CASE DESCRIPTION: THIS REPORT IS FROM A POST-MARKET STUDY. THE STUDY IS UNBLINDED. REPORT RECEIVED ON JULY 7, 2008 AND JULY 14, 2008 FROM AN INVESTIGATOR REGARDING AN (B) (6) MALE, WITH A HISTORY OF OSTEOARTHRITIC KNEE PAIN AND PREVIOUS SYNVISC INJECTION, INITIALS RCG, WHO EXPERIENCED KNEE SWELLING AND KNEE PAIN AFTER STARTING SYNVISC. THE PATIENT PARTICIPATED IN PROTOCOL NUMBER (B) (4) ENTITLED "AN (B) (4) STUDY, (B) (4) STUDY INVESTIGATING THE RELATIONSHIP BETWEEN THE PRESENCE OF HYALURONATE-POSITIVE GRANULOMA AND ACUTE LOCAL REACTIONS ASSOCIATED WITH INTRA-ARTICULAR SYNVISC INJECTION." THE PATIENT RECEIVED INJECTIONS OF SYNVISC INTO THE LEFT KNEE ON (B) (6), 2008, (B) (6), 2008, AND (B) (6), 2008. THREE DAYS AFTER THE THIRD INJECTION, (B) (6), 2008, THE PATIENT HAD "A FLARE" IN THE TARGET KNEE. IT WAS TREATED WITH 1 CC OF CELESTONE. ON (B) (6), 2008, THE PATIENT RETURNED TO THE PHYSICIAN'S OFFICE AND REPORTED PAIN. THERE WAS MILD SWELLING AND EFFUSION NOTED. THE KNEE WAS TREATED WITH 6 MG OF CELESTONE. THE INVESTIGATOR ASSESSED THE RELATIONSHIP OF SYNVISC TO THE EVENTS AS POSSIBLE. THE PATIENT RECOVERED ON AN UNKNOWN DATE.

    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 UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention