BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARGINMARKER

    MDR report key: 20818246 · Received December 2, 2024

    Report

    Report Number
    20818246
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    September 19, 2024
    Report Date
    October 15, 2024
    Manufacturer
    VECTOR SURGICAL, LLC
    Product Code
    MJI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    MARKER PAINT WAS DRY AND NOT WORKING AS IT'S SUPPOSE TO. THE PACKAGE WAS NOT FAULTY, NO BREAK IN STERILITY. SALINE WAS ADDED TO PAINT TO HELP MAKE THE PRODUCT FUNCTIONAL. MANUFACTURER RESPONSE FOR STERILE INK KIT, MARGINMARKER (PER SITE REPORTER). VENDOR FILED A FORMAL COMPLAINT AND ASSIGNED A RMA/CASE NUMBER. THEY REQUESTED SOME PRODUCT FROM THE SAME LOT TO BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94783 MARGINMARKER SPECIMEN/TISSUE, IDENTIFICATION ORIENTATION MJI VECTOR SURGICAL, LLC MM102.0124 AND MM103.0324

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female