BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3161862 · Received June 6, 2013

    Report

    Report Number
    2246315-2013-00344
    Event Type
    Other
    Date Received
    June 6, 2013
    Report Date
    May 29, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    PAIN. SWELLING. CASE DESCRIPTION: SPONTANEOUS REPORT WAS REC'D ON (B)(4) 2013 FROM A HEALTH PROFESSIONAL VIA A COMPANY REP REGARDING A (B)(6) MATE PT, INITIALS (B)(6). THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2012, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION AT A DOSE OF 2 ML (ROUTE AND FREQUENCY NOT PROVIDED) IN LEFT KNEE. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT EXPERIENCED PAIN AND SWELLING. ON AN UNSPECIFIED DATE, THE PT WAS TREATED WITH CORTICOSTEROID INJECTION (UNSPECIFIED) FOR THE EVENT OF PAIN AND SWELLING AND ALSO REC'D SECOND INJECTION OF SYNVISC. THE TREATMENT WITH SYNVISC WAS PERMANENTLY DISCONTINUED DUE TO THE EVENTS OF PAIN AND SWELLING AND THE PT DID NOT RECEIVE THE THIRD SYNVISC INJECTION. THE OUTCOME FOR BOTH WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF PAIN WAS MODERATE AND FOR THE EVENT OF SWELLING WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC AND BOTH THE EVENTS WAS NOT PROVIDED BY THE REPORTING HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251735 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention