BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3096105 · Received April 25, 2013

    Report

    Report Number
    2246315-2013-00131
    Event Type
    Other
    Date Received
    April 25, 2013
    Date of Event
    January 15, 2002
    Report Date
    March 29, 2013
    Manufacturer
    GENZYME BIOSURGERY 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. EVAL SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH RECORD 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 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 [SYNOVITIS]. LEFT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS CASE REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN DATABASE EXTRACTION REGARDING A MALE PT, INITIALS UNK WITH OSTEOARTHRITIS (K&L GRADE 4). 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 PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS USE OF SYNVISC INJECTIONS OF 1ST AND 2ND COURSE. THE PT'S AGE WAS REPORTED TO BE (B)(6) AT THE TIME OF FIRST SYNVISC COURSE. ON (B)(6) 2002, THE PT INITIATED TREATMENT WITH FIRST INTRA-ARTICULAR SYNVISC (HYLAN G-F 20) INJECTION OF THE THIRD COURSE IN LEFT KNEE, DOSAGE REGIMEN NOT PROVIDED. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, ARTHROCENTESIS WAS PERFORMED WHERE 45 CC OF CLEAR YELLOW FLUID WAS ASPIRATED FROM THE LEFT KNEE. ON (B)(6) 2002, THE PT EXPERIENCED SYNOVITIS IN THE LEFT KNEE THAT RECOVERED WITHIN 24 HOURS. THE PT WAS TREATED WITH INTRAMUSCULAR CELESTONE FOR THE EVENT OF SYNOVITIS. THE ACTION TAKEN WITH SYNVISC WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF SYNOVITIS WAS MODERATE AND MILD FOR THE EVENT OF JOINT LEFT KNEE. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SYNOVITIS AS DEFINITELY RELATED AND DID NOT PROVIDE THE RELATIONSHIP WITH THE EVENT JOINT EFFUSION OF LEFT KNEE. F/U INFO WAS RECEIVED ON (B)(6) 2013 AND THE PT INITIALS WERE REPORTED AS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179390 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention