BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3177069 · Received June 12, 2013

    Report

    Report Number
    2246315-2013-00351
    Event Type
    Other
    Date Received
    June 12, 2013
    Report Date
    June 4, 2013
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    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 #Y1115, WITH EXPIRATION DATE 11/2014, WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    RIGHT KNEE BLOWING UP [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN ASSISTANT VIA SALES REP REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6). THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION (ROUTE AND DOSAGE REGIMEN NOT PROVIDED) INTO RIGHT KNEE. ON UNSPECIFIED DATES, THE PT'S RIGHT KNEE WAS "BLOWING UP" AFTER RECEIVING THE FIRST AND THIRD SYNVISC INJECTIONS. HER BLOOD WORK WAS NEGATIVE FOR INFECTION. ON UNSPECIFIED DATES, HER KNEE WAS SCOPED AND WAS TREATED WITH CORTISONE AND SHE WAS REFERRED TO AN IMMUNOLOGIST. AT THE TIME OF REPORT, THE TREATMENT WITH CORTISONE WAS ON-GOING. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT WAS NOT PROVIDED BY THE REPORTING PHYSICIAN ASSISTANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267414 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION UNK Y1115

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention