BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2971938 · Received February 19, 2013

    Report

    Report Number
    2246315-2013-00031
    Event Type
    Other
    Date Received
    February 19, 2013
    Report Date
    February 12, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY WAS RECEIVED ON (B)(4) 2013. 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 IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    RED KNEE [ERYTHEMA]. HOT KNEE [JOINT WARMTH]. SWELLING IN KNEE [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A NURSE VIA SALES REPRESENTATIVE REGARDING A FEMALE PATIENT (AGE NOT PROVIDED), INITIALS UNKNOWN. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT INITIATED TREATMENT WITH SYNVISC ONE (HYLAN G-F 20) INJECTION, IN BOTH KNEES (DOSAGE REGIMEN AND ROUTE OF ADMINISTRATION NOT PROVIDED). THE LOT NUMBER FOR SYNVISC ONE WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED RED KNEE, HOT KNEE AND SWELLING IN ONE KNEE. THE PATIENT WAS TREATED WITH MEDROL (METHYLPREDNISOLONE) DOSEPAK. THE ACTION TAKEN WITH SYNVISC ONE WAS NOT PROVIDED. THE PATIENT RECOVERED FROM THE EVENTS OF RED KNEE, HOT KNEE AND SWELLING OF KNEE AS IT WAS REPORTED THAT THE PATIENT WAS DOING FINE. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE REPORTING NURSE DID NOT PROVIDE THE CAUSAL RELATIONSHIPS BETWEEN SYNVISC ONE AND ALL THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72812 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