BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE

    MDR report key: 7112071 · Received December 12, 2017

    Report

    Report Number
    MW5073930
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    November 9, 2017
    Report Date
    December 12, 2017
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NON SEPTIC REACTION TO SYNVISC ONE. THERAPY DATE: (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: KNEE OSTEOARTHRITIS. "EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886422 SYNVISC ONE ACID HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Disability