BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEO-SITE BONE BIOPSY NEEDLE SET

    MDR report key: 377458 · Received February 19, 2002

    Report

    Report Number
    1820334-2002-00014
    Event Type
    Injury
    Date Received
    February 19, 2002
    Date of Event
    December 27, 2001
    Report Date
    January 16, 2002
    Manufacturer
    COOK INC
    Product Code
    DWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEO-SITE BONE BIOPSY NEEDLE SET NEEDLE DWO COOK INC NA 1089533

    Patients

    Seq Age Sex Outcome Treatment
    1