BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC 16MG/2ML

    MDR report key: 2857735 · Received November 28, 2012

    Report

    Report Number
    MW5027917
    Event Type
    Injury
    Date Received
    November 28, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 28, 2012
    Manufacturer
    GENZYME
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PHARMACY DEPARTMENT EXPERIENCING NUMEROUS ERRORS AND NEAR MISSES DUE TO SIMILARITY IN NDC NUMBERS OF TWO DIFFERENT PRODUCTS: SYNVISC -REGULAR- AND SYNVISC-ONE. SYNVISC-ONE -SINGLE QUARTERLY INJECTION- AND REGULAR SYNVISC -3 INJECTIONS/QUARTER- HAVE ALMOST IDENTICAL NDC'S. ONLY DIFFERENCE BEING THE LAST 2 DIGITS OF THE NDC, WHICH INDICATES JUST A DIFFERENCE IN PACKAGE SIZE. PHARMACY AUTOMATION SYSTEMS THAT ARE IN PLACE CANNOT READ THE DIFFERENCE IN FILLING THE PRODUCT DUE TO THE SIMILARITIES IN NDC'S, LEADING TO MULTIPLE MISFILLS. IE//REGULAR SYNVISC FILLED FOR SYNVISC-ONE PRESCRIPTION; AUTOMATION SCANS AS IF PRODUCT IS CORRECT. WOULD RECOMMEND MAKING MORE CHANGE TO THE NDC NUMBER ON THE PRODUCT SINCE THEY ARE NOT INTERCHANGABLE. AMOUNT: 1 INJ -2ML-, FREQUENCY: QWK X 3, ROUTE: INTRA-ARTICULAR, AND 1 INJ -6ML-, ONCE, INTRA-ARTICULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC 16MG/2ML INJECTION MOZ GENZYME
    2 SYNVISC-ONE 48MG/6ML INJECTION MOZ GENZYME

    Patients

    Seq Age Sex Outcome Treatment
    1