BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMOMARK, 11G MAMMOMARK II

    MDR report key: 2834138 · Received November 8, 2012

    Report

    Report Number
    2834138
    Event Type
    Injury
    Date Received
    November 8, 2012
    Date of Event
    October 12, 2012
    Report Date
    November 7, 2012
    Manufacturer
    DEVICOR MEDICAL PRODUCTS, INC.
    Product Code
    NEU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B)(6) FEMALE PRESENTED TO THE IMAGING CENTER FOR A RIGHT BREAST BIOPSY. DURING THE BIOPSY, A MARKER CLIP WAS ATTEMPTED TO BE INSERTED AND A SECOND CLIP WAS ACTUALLY INSERTED. UPON RETRIEVAL OF THE BIOPSY DEVICE, THE DISTAL TIP WAS CLIPPED AND REMAINS IN THE PT'S BREAST. THIS WAS VERIFIED BY BOTH ULTRASOUND AND MAMMOGRAM. IT WAS REPORTED THAT THE MANUFACTURER WAS CALLED AND THAT IT SHOULDN'T PRESENT ANY CLINICAL CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOMARK, 11G MAMMOMARK II MARKER, BREAST BIOPSY NEU DEVICOR MEDICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other