BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2625845 · Received June 11, 2012

    Report

    Report Number
    2246315-2012-00168
    Event Type
    Other
    Date Received
    June 11, 2012
    Report Date
    June 3, 2012
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON 06-JUNE-2012. 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. MFR¿S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    INCAPACITATING MUSCLE PAIN (MYALGIA). INCAPACITATING JOINT PAIN (ARTHRALGIA). CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON 03-JUN-2012 FROM A HEALTH CARE PROFESSIONAL REGARDING A PT, INITIALS (B)(6). THE PT¿S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT INITIATED SYNVISC (HYLAN G-F 20) INJECTION, DOSE REGIMEN NOT PROVIDED. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT EXPERIENCED INCAPACITATING JOIN PAIN AND INCAPACITATING MUSCLE PAIN. IT WAS REPORTED THAT THE PT ¿FELT LIKE MY BODY WAS REJECTING THE MEDICATION¿ AND PAIN WORSENED WITH TIME UNTIL TREATED WITH MEDROL (METHYL PREDNISOLONE) DOSEPAK. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENTS OF INCAPACITATING JOINT PAIN AND INCAPACITATING MUSCLE PAIN AND WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS OF INCAPACITATING JOINT PAIN AND INCAPACITATING MUSCLE PAIN WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF INCAPACITATING JOINT PAIN AND INCAPACITATING MUSCLE PAIN WERE NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention