BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3181999 · Received June 14, 2013

    Report

    Report Number
    2246315-2013-00357
    Event Type
    Other
    Date Received
    June 14, 2013
    Report Date
    June 7, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    LEFT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS CASE WAS RECEIVED ON (B)(6) 2013 FROM A HEALTH CARE PROFESSIONAL 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) IN LEFT KNEE. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, TWO DAYS AFTER INITIATION OF TREATMENT WITH SYNVISC, THE PT WAS TAKEN TO THE EMERGENCY ROOM. IT WAS REPORTED THAT THE HOSPITAL RULED OUT DEEP VEIN THROMBOSIS AND THE PT'S SEDIMENTATION RATE WAS NORMAL. ON AN UNSPECIFIED DATE, THE PT RETURNED TO THE CLINIC AND THE PHYSICIAN ASPIRATED 60 ML OF FLUID FROM THE LEFT KNEE OF PT. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE PT RECOVERED FROM THE EVENT. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN SYNVISC AND THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271510 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention