BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3085081 · Received April 25, 2013

    Report

    Report Number
    2246315-2013-00299
    Event Type
    Other
    Date Received
    April 25, 2013
    Date of Event
    March 6, 2000
    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 12-APR-2013. 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 [SYNOVITIS]. LEFT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN DATABASE EXTRACTION REGARDING A (B)(6) MALE PATIENT, INITIALS UNK, WITH OSTEOARTHRITIS (GRADE 3). 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 NOT PROVIDED. ON (B)(6) 2000. THE PATIENT RECEIVED THE THIRD INTRA-ARTICULAR SYNVISC (HYLAN G-F 20) INJECTION OF THE FIRST COURSE (DOSAGE REGIMEN NOT PROVIDED) INTO THE LEFT KNEE. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. IT WAS REPORTED THAT THE PATIENT HAD A TRACE EFFUSION PRIOR TO THE INJECTION. ON (B)(6) 2000, THE PATIENT DEVELOPED LEFT KNEE EFFUSION AND 90CC OF SLIGHT CLOUDY YELLOW FLUID WAS ASPIRATED FROM THE LEFT KNEE. THE PATIENT ALSO RECEIVED 02CC OF INTRAMUSCULAR CELESTONE (BETAMETHASONE SODIUM PHOSPHATE). ON (B)(6) 2000, THE PATIENT RECOVERED FROM THE SYNOVITIS. THE OUTCOME FOR THE EVENT OF LEFT KNEE EFFUSION WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS OF SYNOVITIS AND LEFT KNEE EFFUSION WAS ASSESSED AS SEVERE. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SYNOVITIS AS DEFINITE BUT DID NOT PROVIDE A CAUSAL RELATIONSHIP FOR THE EVENT OF LEFT KNEE EFFUSION. 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
    179358 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention