BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3205180 · Received June 28, 2013

    Report

    Report Number
    2246315-2013-00377
    Event Type
    Other
    Date Received
    June 28, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 19, 2013
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2013. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER V1213, EXPIRY DATE 08/01/2015 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    EXTREME SWELLING IN KNEES [JOINT SWELLING]. PAIN IN KNEES [ARTHRALGIA]. KNEES HAD TO BE DRAINED [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM AN OTHER NON-HEALTH PROFESSIONAL REGARDING A (B)(6) FEMALE PATIENT, INITIALS UNKNOWN. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2013, THE PATIENT INITIATED TREATMENT WITH FIRST SYNVISC (HYLAN G-F 20) INJECTION, (ROUTE OF ADMINISTRATION AND DOSAGE REGIMEN NOT PROVIDED) IN AN UNSPECIFIED KNEE. ON (B)(6) 2013, THE PATIENT RECEIVED SECOND SYNVISC INJECTION. ON AN UNSPECIFIED DATE IN (B)(6) 2013, THE PATIENT DEVELOPED EXTREME SWELLING IN KNEES, PAIN IN KNEES AND THE KNEES HAD TO BE DRAINED AFTER BOTH THE INJECTIONS. THE PATIENT ALSO RECEIVED TREATMENT WITH STEROID INJECTIONS. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR ALL THE EVENTS WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE CAUSAL RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF EXTREME SWELLING IN KNEES, PAIN IN KNEES AND KNEES HAD TO BE DRAINED WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296151 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY UNK V1213

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention