BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMARC G/T¿

    MDR report key: 8775367 · Received July 9, 2019

    Report

    Report Number
    8775367
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    June 3, 2019
    Report Date
    June 11, 2019
    Manufacturer
    CORTEX MANUFACTURING INC.
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    10MM SPACED FIDUCIALS WERE RECEIVED FROM CIVCO RADIOTHERAPY IN PACKAGING LABELED 20MM SPACED FIDUCIALS. MULTIPLE PACKAGES RECEIVED MISLABELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568014 FLEXIMARC G/T¿ MARKER, RADIOGRAPHIC, IMPLANTABLE NEU CORTEX MANUFACTURING INC. FM-1.0-2-10-GT-18-20

    Patients

    Seq Age Sex Outcome Treatment
    1