BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3096072 · Received April 25, 2013

    Report

    Report Number
    2246315-2013-00222
    Event Type
    Other
    Date Received
    April 25, 2013
    Date of Event
    September 28, 2004
    Report Date
    March 29, 2013
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON 04/09/2013. 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. MFR'S COMMENT: THIS CASE REPORT BELONGS TO A BATCH OF (B)(4) FROM A DATABASE EXTRACTION CONTAINING A COLLECTION OF DATA FROM (B)(6) 1997 TO (B)(6) 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 WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN DATABASE EXTRACTION REGARDING A FEMALE PATIENT, INITIALS UNK WITH OSTEOARTHRITIS (GRADE 2, NO EFFUSION). (B)(4). THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS USE OF (IT WAS REPORTED THAT THE AGE OF THE PATIENT AT THE TIME OF FIRST COURSE OF SYNVISC INJECTION WAS (B)(6)). ON (B)(6) 2004, THE PATIENT INITIATED TREATMENT WITH SECOND COURSE OF FIRST INTRA-ARTICULAR SYNVISC (HYLAN G-F 20) INJECTION, DOSAGE REGIMEN NOT PROVIDED, IN BOTH KNEES. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 2004, THE PATIENT EXPERIENCED SYNOVITIS OF BOTH KNEES FOR WHICH SHE RECEIVED TREATMENT WITH INTRAMUSCULAR BETAMETHASONE, AT A DOSE OF 1.3 CC. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS ASSESSED AS MILD. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SYNOVITIS OF BOTH KNEES AS DEFINITELY RELATED. FOLLOW-UP INFO WAS RECEIVED ON (B)(6) 2013 AND THE PATIENT INITIALS WERE REPORTED AS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179170 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