BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1981206 · Received January 27, 2011

    Report

    Report Number
    2246315-2011-00012
    Event Type
    Other
    Date Received
    January 27, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 14, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT. 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.

    Description of Event or Problem · 1

    JOINT FLUID RETENTION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6)-2011 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PATIENT, INITIALS (B)(6), WITH A RELEVANT MEDICAL HISTORY OF OSTEOARTHRITIS, RHEUMATISM AND PSORIASIS. THE PATIENT RECEIVED THE FIRST SYNVISC INJECTION OF 2 ML ON (B)(6)-2011. THE SYNVISC LOT NUMBER WAS UNKNOWN. ON (B)(6)-2011, THE PATIENT DEVELOPED JOINT FLUID RETENTION. ON (B)(6)-2011, THE PATIENT VISITED THE HOSPITAL AND THE KNEE WAS ASPIRATED OF 100CC JOINT FLUID. THE PATIENT DID NOT RECEIVE THE LAST TWO INJECTIONS AND THE PRODUCT WAS PERMANENTLY STOPPED ON (B)(6)-2011. THE CONCOMITANT THERAPY FOR RHEUMATISM INCLUDED METHOTREXATE WHICH WAS STARTED IN (B)(6)-2010 AND FOLIC ACID, CELECOXIB, AZULENE SULFONATE SODIUM, WHICH WERE STARTED ON (B)(6)-2011 AND THE CONCOMITANT THERAPY IS STILL CONTINUING. THE PHYSICIAN ASSESSED THE RELATION OF THE EVENTS AS NON-SERIOUS AND PROBABLY RELATED TO SYNVISC. ON (B)(6)-2011, THE PATIENT OUTCOME WAS REPORTED AS RECOVERING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention FOLIC ACID (FOLIC ACID) UNK| CELECOXIB (CELECOXIB) UNK| AZULENE SULFONATE SODIUM UNK| METHOTREXATE (METHOTREXATE SODIUM) UNK