BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBC II

    MDR report key: 493869 · Received November 3, 2003

    Report

    Report Number
    1811755-2003-00043
    Event Type
    Injury
    Date Received
    November 3, 2003
    Date of Event
    September 30, 2003
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PORTION OF WOUND DRAIN BROKE OFF INSIDE OF PATIENT AT THE TIME DRAIN WAS REMOVED. PIECE WAS DISCOVERED ON AN X-RAY ONE WEEK POST-OP. WOUND DRAIN PIECE WAS REMOVED THREE WEEKS POST-OP THROUGH A SMALL INCISION IN THE HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC II APPARATUS, AUTO TRANSFUSION CAC STRYKER INSTRUMENTS 0225-414-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention