BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC-ONE

    MDR report key: 7326973 · Received March 9, 2018

    Report

    Report Number
    7326973
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    December 12, 2017
    Report Date
    February 16, 2018
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED AN ULTRASOUND GUIDED INJECTION OF SYNVISC-ONE. PATIENT PRESENTED WITH LEFT KNEE PAIN AND REPORTS STABBING PAIN BEGAN AT APPROXIMATELY 16:00 THAT SAME DAY (APPROXIMATELY 8 HOURS POST INJECTION). GROWTH OF A GRAM NEGATIVE BACILLUS WAS DETECTED FROM THE SYNOVIAL FLUID CULTURE COLLECTED. MANUFACTURER HAS ISSUED A RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171402 SYNVISC-ONE ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION HYLAN G-F-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other OTHER, PATIENT RECEIVED AN ULTRASOUND GUIDED INJ