BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST LESION LOCALIZATION NEEDLE

    MDR report key: 35293 · Received July 16, 1996

    Report

    Report Number
    35293
    Event Type
    Injury
    Date Received
    July 16, 1996
    Date of Event
    April 9, 1996
    Report Date
    April 19, 1996
    Manufacturer
    BECTON-DICKINSON & CO.
    Product Code
    MIJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD NEEDLE LOCALIZATION AND BREAST BIOPSY PERFORMED ON 1/18/96. ON 4/9/96, A SECOND BIOPSY WAS PERFORMED AND A TWO INCH SEGMENT OF THE WIRE USED FOR NEEDLE LOCALIZATION WAS FOUND IN THE BREAST. IT APEARS THIS SEGMENT BROKE OFF DURING TISSUE DISSECTION ON 1/18/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREAST LESION LOCALIZATION NEEDLE Implant NEEDLE AND HOOK WIRE MIJ BECTON-DICKINSON & CO. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention