BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOLOGIC SECURMARK

    MDR report key: 2501086 · Received March 16, 2012

    Report

    Report Number
    MW5024726
    Event Type
    Other
    Date Received
    March 16, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 16, 2012
    Manufacturer
    HOLOGIC
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS A 1.5 CM HIGH DENSITY TUBULAR DENSITY WITH A CIRCUMSCRIBED MARGIN IN THE LEFT BREAST AT 7 O'CLOCK ANTERIOR DEPTH. THIS WAS SEEN IN ADD'L VIEWS. TARGETED ULTRASOUND DEMONSTRATES A 1.5 CM MASS. THIS CORRELATES WITH MAMMOGRAPHY FINDINGS. AN ATTEMPT WAS MADE TO PLACE AN 11 GAUGE CLIP INTO THE CAVITY. TECHNICIAN WATCHED THE CLIP BEING INTRODUCED ON ULTRASOUND BUT WHEN THE MAMMOTOME DEVICE WAS REMOVED, THE CLIP IN ITS COLLAGEN WAS STILL AT THE TIP. IT DID NOT DEPLOY PROPERLY INTO THE BREAST. A 14 GAUGE CLIP WAS INTRODUCED BY HAND AND PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLOGIC SECURMARK BREAST BIOPSY SITE MARKER NEU HOLOGIC 1201001A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other