BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTA-VAC AUTOTRANSFUSION SYSTEM

    MDR report key: 22240 · Received May 12, 1995

    Report

    Report Number
    22240
    Event Type
    Injury
    Date Received
    May 12, 1995
    Date of Event
    March 10, 1995
    Report Date
    April 11, 1995
    Manufacturer
    STRYKER, INC.
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD TOTAL KNEE REPLACEMENT 3/9/95. MD PLACED 2 DRAINS FOR THE AUTO-TRANSFUSION SEPTUM. MD ORDERED ON 3/10 FOR THE DRAINS TO BE REMOVED. ONE REMOVED EASILY, MD HAD TO REMOVE OTHER ONE. THE SECOND ONE BROKE ON REMOVAL REQUIRING THE PT RETURN TO SURGERY FOR REMOVAL OF THE RETAINED PART OF THE DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTA-VAC AUTOTRANSFUSION SYSTEM AUTOTRANSFUSION SYSTEM CAC STRYKER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R