BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2170178 · Received June 24, 2011

    Report

    Report Number
    2246315-2011-00148
    Event Type
    Other
    Date Received
    June 24, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 16, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    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

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 IN THE FORM OF QA RESULTS. 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. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT WAS NOT AFFECTED BY THE REPORT.

    Description of Event or Problem · 1

    KNEE SWELLING [JOINT SWELLING]. KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011 FROM A GENZYME REPRESENTATIVE ON BEHALF OF A HEALTH CARE PROFESSIONAL REGARDING A MALE PATIENT, INITIALS UNKNOWN, WHO EXPERIENCED KNEE SWELLING AND EFFUSION AFTER STARTING SYNVISC. IN (B)(6) 2011, THE PATIENT INITIATED SYNVISC TREATMENT. AFTER RECEIVING THE SECOND INJECTION, THE PATIENT DEVELOPED KNEE SWELLING AND EFFUSION, WHICH REQUIRED KNEE JOINT ASPIRATION (DATE NOT PROVIDED). THE SYNOVIAL FLUID CULTURE WAS NEGATIVE. TWO DAYS LATER, THE PATIENT'S KNEE SWELLING WORSENED AND HIS KNEE WAS ASPIRATED ONCE MORE. THE HCP REPORTED THAT THE FLUID WAS "PUS-LIKE," BUT THAT THERE WAS NO SIGN OF INFECTION. THE PATIENT REQUIRED ADDITIONAL TREATMENT FOR HIS SYMPTOMS IN THE FORM OF INTRA-ARTICULAR CORTISONE INJECTIONS IN HIS KNEE (DATE NOT PROVIDED). THE PRODUCT LOT NUMBER WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PATIENT WAS UNKNOWN.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention