BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 3261287 · Received July 31, 2013

    Report

    Report Number
    2246315-2013-00415
    Event Type
    Other
    Date Received
    July 31, 2013
    Report Date
    July 22, 2013
    Manufacturer
    GENZYME CORPORATION (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY WAS RECEIVED ON (B)(4) 2013. EVALUATION 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 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. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC ONE IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    RED KNEE [ERYTHEMA], HOT KNEE [JOINT WARMTH], PAINFUL KNEE [ARTHRALGIA], KNEE JOINT EFFUSION [JOINT EFFUSION], WBC COUNT IN FLUID WAS 33,497 [SYNOVIAL FLUID WHITE BLOOD CELLS POSITIVE]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A HEALTH CARE PROFESSIONAL REGARDING A (B)(6) MALE PATIENT, INITIALS (B)(6). THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT INITIATED TREATMENT WITH SYNVISC-ONE (HYLAN G-F 20) INJECTION, ROUTE OF ADMINISTRATION AND DOSAGE REGIMEN NOT PROVIDED IN AN UNSPECIFIED LOCATION. THE LOT NUMBER FOR SYNVISC-ONE WAS NOT PROVIDED. TWENTY FOUR HOURS AFTER INJECTION, THE PATIENT DEVELOPED RED, HOT AND PAINFUL KNEE. ON AN UNSPECIFIED DATE, THE PATIENT DEVELOPED KNEE EFFUSION, FOLLOWING WHICH BROWNISH YELLOW AND CLOUDY FLUID WAS DRAINED AND CORTISONE INJECTION WAS ADMINISTERED. THE SYNOVIAL FLUID ANALYSIS REVEALED, WHITE BLOOD CELL COUNT OF 33,497, HOWEVER, NO BACTERIA WAS PRESENT. THE ACTION TAKEN WITH SYNVISC-ONE TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENTS OF RED KNEE, HOT KNEE, PAINFUL KNEE, KNEE EFFUSION AND WHITE BLOOD CELL COUNT IN FLUID 33,497 WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE REPORTING HEALTH CARE PROFESSIONAL DID NOT PROVIDE THE RELATIONSHIP OF SYNVISC-ONE WITH ALL THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358256 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention