BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBC II

    MDR report key: 462216 · Received May 22, 2003

    Report

    Report Number
    2648666-2003-20001
    Event Type
    Injury
    Date Received
    May 22, 2003
    Date of Event
    April 5, 2003
    Report Date
    April 28, 2003
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON ATTEMPT OF REMOVAL, DRAIN BROKE OFF. ADDITIONAL SURGERY WAS NEEDED TO FINISH REMOVAL. NO PERMANENT INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC II APPARATUS, AUTO TRANSFUSION CAC STRYKER INSTRUMENTS 0225-028-914 03030192

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention