BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLANG G-F 20) INJECTION

    MDR report key: 2112451 · Received March 21, 2011

    Report

    Report Number
    2246315-2011-00050
    Date Received
    March 21, 2011
    Date of Event
    October 1, 2010
    Report Date
    March 10, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT. 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 CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. 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

    RIGHT KNEE SWELLING [JOINT SWELLING]. ASPIRATED THE KNEE [JOINT EFFUSION]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011 FROM A (B)(6) FEMALE PATIENT WITH A HISTORY OF OSTEOARTHRITIS OF THE KNEE, INITIALS (B)(6), WHO EXPERIENCED RIGHT KNEE SWELLING AND HAD THE RIGHT KNEE ASPIRATED AFTER STARTING SYNVISC. THE PATIENT HAS RECEIVED SYNVISC IN THE PAST, ABOUT A YEAR AGO. IN THE CURRENT SERIES, THE PATIENT RECEIVED AN INJECTION OF SYNVISC IN THE RIGHT KNEE IN (B)(6) 2010. AFTER RECEIVING SYNVISC, THE PATIENT EXPERIENCED RIGHT KNEE SWELLING. THE PATIENT VISITED THE PHYSICIAN AND HER KNEE WAS ASPIRATED. THE PATIENT IS UNSURE IF ANY FLUID WAS WITHDRAWN. THE PATIENT ALSO RECEIVED AN INTRA-ARTICULAR INJECTION OF CORTISONE. THE PATIENT DID NOT RECEIVE THE SECOND AND THIRD SYNVISC INJECTIONS OF THE SERIES. ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED IN THE FORM OF QA RESULTS WITHOUT A LOT NUMBER. 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 CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLANG G-F 20) INJECTION NONE MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other