BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNVISC

    MDR report key: 12377063 · Received August 26, 2021

    Report

    Report Number
    MW5103519
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Report Date
    October 2, 2020
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    I WANTED TO REPORT THE BELOW MANUFACTURER ERROR TO (B)(6) AND THOUGHT SENDING THE PIES VIA EMAIL WOULD BE BEST. THE 30 QR BARCODE ON THE SYNVISC (HYALURONATE) BOX IS SCANNING AS KYNAMRO (MIPOMERSEN). IT APPEARS THAT THE GTIN# (B)(4) INCORRECTLY INCLUDES THE NDC OF THE KYNAMRO ((B)(4)). GENZYME HAS BEEN NOTIFIED BUT WE HAVEN'T HEARD BACK YET. TYPE: WRONG DRUG PREPARATION. CONTRIBUTING FACTORS: UNAUTHORIZED SUBSTITUTION / WRONG BRAND MFR / LABELER. SPECIAL CODE: MFR CORRECTIVE ACTION. SEVERITY: CIRCUMSTANCES OR EVENTS HAVE CAPACITY TO CAUSE ERROR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272416 SYNVISC ACID, HYALURONIC, INTRAARTICULAR MOZ GENZYME CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1