BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 506211 · Received January 12, 2004

    Report

    Report Number
    2246315-2004-00005
    Event Type
    Injury
    Date Received
    January 12, 2004
    Date of Event
    August 19, 2003
    Report Date
    January 12, 2004
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DIZZINESS, SWEATING, NAUSEA, VOMITTING. INFO WAS RECEIVED IN 2003 FROM THE FDA REGARDING A PHARMACIST REPORT ON AN UNIDENTIFIED PT WHO RECEIVED A SYNVISC INJECTION IN 2003 (INDICATION AND JOINT UNSPECIFIED). AT THE TIME OF THE INJECTION, THE PT BEGAN FEELING DIZZY AND SWEATING AND THEN EXPERIENCED NAUSEA AND VOMITING. THE PT EXPERIENCED THE SAME REACTION AND SYMPTOMS DURING THE ADMINISTRATION OF THE SECOND INJECTION (DATE NOT PROVIDED). THE PT WAS HOSPITALIZED FOR FLUID REPLACEMENT AND MONITORING (DATES NOT PROVIDED). AT THE TIME OF THIS REPORT, THE PT'S OUTCOME IS UNK. QA INVESTIGATION RESULTS: QA PERFORMED A REVIEW OF THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT #P0305. ALL DOCUMENTATION ARE COMPLETE AND IN ORDER. THE PRODUCT MET SPECIFICATIONS AT RELEASE. NO ASSOCIATED NON-CONFORMANCE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC HYLAN G-F 20 MOZ GENZYME CORPORATION NA P0305

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R