BEUDAMED
    FDA Adverse Event Other Summary report: N

    LESION LOCALIZATION NEEDLE

    MDR report key: 547591 · Received September 23, 2004

    Report

    Report Number
    547591
    Event Type
    Other
    Date Received
    September 23, 2004
    Date of Event
    January 23, 2003
    Report Date
    September 23, 2004
    Manufacturer
    COOK BO/GYN
    Product Code
    MIJ
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR EXCISIONAL BIOPSY OF THE LEFT BREAST MASS WITH NEEDLE LOCALIZATION. INTRAOPERATIVELY, THE TIP OF ONE OF THE WIRES WAS NOTED TO BE MISSING. MAMMOGRAPHY PERFORMED REVEALED A LINEAR METALLIC DENSITY AT THE SURGICAL SITE REPRESENTING A WIRE TIP. NEEDLE LOCALIZATION AND EXCISION WAS PERFORMED. PATHOLOGY REPORT REVEALED A DETACHED NEEDLE TIP EMBEDDED IN THE SPECIMEN MEASURING .5 CENTIMETERS IN LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LESION LOCALIZATION NEEDLE LESION LOCALIZATION NEEDLE MIJ COOK BO/GYN * UF1173982

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR NO OTHER THERAPIES