BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDITECH BOSTON SCIENTIFIC CORP

    MDR report key: 309593 · Received December 21, 2000

    Report

    Report Number
    MW1020664
    Event Type
    Injury
    Date Received
    December 21, 2000
    Date of Event
    December 5, 2000
    Report Date
    December 13, 2000
    Manufacturer
    MEDITECH BOSTON SCIENTIFIC CO
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A CORE BIOPSY OF THE ABDOMEN THE CORE NEEDLE BROKE OFF INSIDE THE FASCIA. CT SCAN CONFIRMED THE NEEDLE FRAGMENT 1.8 CM INTO THE ABDOMINAL WALL. THE RADIOLOGIST SNARED THE FRAGMENT WITH KELLY CLAMPS. THE FRAGMENT WAS APPROX 1 INCH IN LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITECH BOSTON SCIENTIFIC CORP SURECUT BIOPSY NEEDLE KNW MEDITECH BOSTON SCIENTIFIC CO * 8217

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention