BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC-ONE

    MDR report key: 7645623 · Received June 27, 2018

    Report

    Report Number
    MW5078121
    Event Type
    Injury
    Date Received
    June 27, 2018
    Date of Event
    June 14, 2018
    Report Date
    June 25, 2018
    Manufacturer
    SANOFI-AVENTIS / GENZYME CORP.
    Product Code
    MOZ
    UDI-DI
    58468009003
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED SYNVISC-ONE INJECTION ON (B)(6) 2018 FOR OSTEOARTHRITIS. THIS IS AN ADD ON TO THE INITIAL REPORT FILED FOR THIS PATIENT. PATIENT RETURNED TO THE HOSPITAL 2 DAYS LATER ON (B)(6) 2018 WITH SIGNIFICANT KNEE PAIN. SHE WAS DIAGNOSED WITH A SEPTIC KNEE, HAD PURULENT DRAINAGE, AND UNDERWENT A R. KNEE WASHOUT. THERAPY START DATE: (B)(6) 2018. THERAPY END DATE: (B)(6) 2018. DIAGNOSIS: OSTEOARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486752 SYNVISC-ONE SYNVISC-ONE MOZ SANOFI-AVENTIS / GENZYME CORP. 7RSL049 58468009003

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization