BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1212762 · Received October 27, 2008

    Report

    Report Number
    2246315-2008-00156
    Event Type
    Other
    Date Received
    October 27, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 16, 2008
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    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 SPEC CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPEC 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.

    Description of Event or Problem · 1

    LOCAL KNEE PAIN [ARTHRALGIA], LOCAL KNEE SWELLING [JOINT SWELLING], KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B) (6) 2008 FROM A PHYSICIAN ASSISTANT, VIA A SALES REP, REGARDING A FEMALE PT WITH OSTEOARTHRITIS. THE PT RECEIVED THREE INJECTIONS OF SYNVISC IN THE KNEE ON UNK DATES, THE LAST OF WHICH WAS GIVEN IN (B) (6) 2008. SEVERAL DAYS AFTER THE THIRD INJECTION, THE PT EXPERIENCED LOCAL PAIN AND SWELLING. ON (B) (6) 2008, THE PT HAD 60ML OF FLUID ASPIRATED FROM THE TREATED KNEE. THE FLUID WAS SENT FOR EVAL AND WAS FOUND TO BE NORMAL. THE PT RETURNED TO THE PHYSICIAN'S OFFICE ON (B) (6) 2008 AND HAD ANOTHER 60ML OF FLUID DRAINED FROM THE KNEE. THE PT WAS GIVEN AN INJECTION OF CORTISONE. AS OF THE DATE OF RECEIPT OF THE REPORT, THE PT'S OUTCOME 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