BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3084993 · Received April 25, 2013

    Report

    Report Number
    2246315-2013-00110
    Event Type
    Other
    Date Received
    April 25, 2013
    Date of Event
    February 5, 2004
    Report Date
    March 29, 2013
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE 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. MFR¿S COMMENT: THIS CASE REPORT BELONGS TO A BATCH OF ICSRS FROM A DATABASE EXTRACTION CONTAINING A COLLECTION OF DATA FROM OCTOBER 1997 TO JULY 2010. THE BENEFIT-RISK PROFILE OF THE PRODUCT IS NOT ALTERED BY THIS REPORT.

    Description of Event or Problem · 1

    SYNOVITIS. CASE DESCRIPTION: SPONTANEOUS CASE REPORT WAS RECEIVED ON (B)(4) 2013 FROM A PHYSICIAN DATABASE EXTRACTION REGARDING A FEMALE PATIENT, INITIALS UNKNOWN, WITH GRADE 03 OSTEOARTHRITIS. THIS CASE BELONGS TO A BATCH OF ICSRS FROM A COMPANY PURCHASED DATABASE CONTAINING A COLLECTION OF DATA FROM OCTOBER 1997 TO JULY 2010. THE PATIENT¿S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS TREATMENT WITH FIRST COURSE OF SYNVISC (HYLAN G-F 20) INJECTION ((B)(6) AT THE TIME OF FIRST COURSE) ON (B)(6) 2004, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION (OF SECOND COURSE) IN THE RIGHT KNEE (DOSAGE REGIMEN NOT PROVIDED). THE LOT NUMBER FOR DOSE REGIMEN WAS NOT PROVIDED. ON (B)(6) 2004, THE PATIENT EXPERIENCED SYNOVITIS OF RIGHT KNEE. ON AN UNSPECIFIED DATE IN 2004, THE PATIENT RECEIVED TREATMENT WITH BETAMETHASONE FOR THE EVENT OF SYNOVITIS. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. ON (B)(6) 2004 (AFTER 48 HOURS), THE PATIENT RECOVERED FROM THE EVENT OF SYNOVITIS OF RIGHT KNEE. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF SYNOVITIS WAS ASSESSED AS MILD. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SYNOVITIS AS DEFINITELY RELATED. FOLLOW-UP INFO WAS RECEIVED ON (B)(4) 2013 AND THE PATIENT INITIALS WERE REPORTED AS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180619 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention