BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2222647 · Received July 15, 2011

    Report

    Report Number
    2246315-2011-00171
    Date Received
    July 15, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 7, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, ADDITIONAL INFORMATION WAS RECEIVED IN THE FORM OF QA RESULTS W/O A LOT NUMBER. 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 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 IS NOT AFFECTED BY THE REPORT.

    Description of Event or Problem · 1

    PARALYSIS IN RIGHT LEG [MONOPLEGIA]. UNABLE TO PUT PRESSURE ON RIGHT LEG [WEIGHT BEARING DIFFICULTY]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011, FROM A CONSUMER REGARDING A FEMALE PATIENT, INITIALS (B)(6), UNKNOWN WITH OSTEOARTHRITIS. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR OSTEOARTHRITIS. ON (B)(6) 2011, THE PATIENT INITIATED TREATMENT WITH SYNVISC-ONE IN THE RIGHT KNEE. THE PATIENT ALSO RECEIVED CORTISONE ON THE SAME DAY AS SYNVISC-ONE. THE PATIENT REPORTED THAT SINCE (B)(6) 2011, THE PATIENT CONTINUES TO FEEL PARALYSIS IN THE RIGHT LEG AND IS UNABLE TO PUT PRESSURE ON THE RIGHT LEG. THE PATIENT IS ONLY ABLE TO SIT. THE PATIENT HUNG UP THE PHONE DURING THE CONVERSATION WITH THE COMPANY REPRESENTATIVE AND THUS COMPLETE INFORMATION COULD NOT BE OBTAINED FROM THE PATIENT. ACTION TAKEN WITH SYNVISC-ONE WAS NOT PROVIDED. 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 Other