BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 1981198 · Received January 26, 2011

    Report

    Report Number
    2246315-2011-00011
    Event Type
    Other
    Date Received
    January 26, 2011
    Report Date
    January 18, 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

    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 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 ASSUMING 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

    GRAM STAIN CAME BACK POSITIVE FOR (B)(6). OBTAINED FLUID FROM KNEE [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2011 FROM A HEALTH CARE PROVIDER, VIA A COMPANY REPRESENTATIVE, REGARDING A FEMALE PATIENT (UNKNOWN AGE AND INITIALS). THE PATIENT HAD A HISTORY OF OSTEOARTHRITIS. THE PATIENT EXPERIENCED KNEE EFFUSION AND HAD A POSITIVE GRAM STAIN FOR (B)(6) AFTER RECEIVING SYNVISC-ONE. ON AN UNSPECIFIED DATE, THE PATIENT HAD BILATERAL KNEE INJECTIONS OF SYNVISC-ONE. THREE TO FOUR DAYS LATER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND THE EMERGENCY ROOM PHYSICIAN OBTAINED FLUID FROM THE KNEE FOR A GRAM STAIN. THE GRAM STAIN CAME BACK POSITIVE FOR (B)(6) AND THE FLUID WAS CULTURED AND RESULTS WERE NEGATIVE. THE PATIENT HAD AN ARTHROSCOPIC PROCEDURE PERFORMED TO CLEAN OUT THE KNEE. DATES OF THE ARTHROSCOPIC PROCEDURE AND DATES OF THE EVENTS WERE UNKNOWN. THE HEALTH CARE PROVIDER REPORTED THE PATIENT'S ADVERSE EVENTS HAD A DEFINITE RELATIONSHIP WITH SYNVISC-ONE. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 IN THE FORM OF QA RESULTS. 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. THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC ONE (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