BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE 45MG/6ML

    MDR report key: 7288833 · Received February 22, 2018

    Report

    Report Number
    MW5075406
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    November 14, 2017
    Report Date
    December 12, 2017
    Manufacturer
    GENZYME CORP.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SYNVISC ONE WAS INJECTED INTO BOTH KNEES FOR PATIENT. WITHIN 4 HOURS PATIENT HAD SEVERE PAIN, STIFFNESS, SWELLING. DOSE OR AMOUNT: A 45 MG/6ML. FREQUENCY: SIX MONTHS. ROUTE: INTRAARTICULAR. DOSE OR AMOUNT: A 48 MG/ 6 ML. FREQUENCY: SIX MONTHS. ROUTE: INTRAARTICULAR. DATES OF USE: (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: M1711 RIGHT DJD OF KNEE. M17.12 L DJD OF KNEE. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131842 SYNVISC ONE 45MG/6ML ACID HYALURONIC MOZ GENZYME CORP. 7RSL021

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other