BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBC II WOUND DRAIN

    MDR report key: 297119 · Received September 19, 2000

    Report

    Report Number
    2648666-2000-00047
    Event Type
    Injury
    Date Received
    September 19, 2000
    Date of Event
    May 18, 2000
    Report Date
    June 8, 2000
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE DOCTOR WAS REMOVING WOUND DRAIN, DRAIN BROKE LEAVING A PIECE OF DRAIN TUBING IN THE WOUND SITE. A SECOND SURGERY WAS NEEDED TO REMOVE THE PIECE OF TUBING. THE BROKEN PIECE OF TUBING WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC II WOUND DRAIN APPARATUS, AUTO TRANSFUSION GCY STRYKER INSTRUMENTS 0215-015-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention