BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGSEED

    MDR report key: 20722870 · Received November 19, 2024

    Report

    Report Number
    20722870
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 11, 2024
    Report Date
    October 30, 2024
    Manufacturer
    ENDOMAGNETICS LTD
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ULTRASOUND MAGSEED PLACEMENT ON PATIENT PERFORMED. MAMMOGRAM WAS OBTAINED AFTERWARDS AND ONLY ONE MAGSEED WAS IDENTIFIED WHEN TWO WERE PLACED. WE REIMAGED PATIENT UNDER ULTRASOUND AND ALSO COULD NOT FIND 2ND MAGSEED, SO RADIOLOGIST PLACED A NEW MAGSEED INTO THE PATIENT. THE SONOGRAPHER TOOK REPRESENTATIVE PICTURES OF BOTH MAGSEED IN PLACE AND PATIENT WENT TO MAMMOGRAM FOR ADDITIONAL ACKNOWLEDGEMENT OF PLACEMENT. COULD NOT DETERMINE WHICH MAGSEED WAS DEFECTIVE DUE TO BOTH WERE PLACED ON STERILE TRAY AT THE BEGINNING OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307502 MAGSEED MARKER, RADIOGRAPHIC, IMPLANTABLE NEU ENDOMAGNETICS LTD SM18-1-12US 220819-94

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female