BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK

    MDR report key: 377456 · Received February 19, 2002

    Report

    Report Number
    MW4003161
    Event Type
    Injury
    Date Received
    February 19, 2002
    Date of Event
    December 27, 2001
    Report Date
    December 27, 2001
    Manufacturer
    COOK INC.
    Product Code
    DWO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OSTEO-SITE BONE BIOPSY NEEDLE WAS TAPPED INTO PLACE IN T-7 VERTEBRAL BODY. WHEN THE NEEDLE WAS BEING REMOVED BY HAND THE HANDLES SEPARATED FROM THE NEEDLE. THE NEEDLE WAS EXTRACTED INTACT AND THE PT DID NOT INCUR ANY INJURIES. DR., RADIOLOGIST, PERFORMED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK OSTEO-SITE BONE BIOPSY NEEDLE DWO COOK INC. DBBN-13-10.0 1089533

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention