BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBC BLOOD CONSERVATION KIT

    MDR report key: 201410 · Received December 11, 1998

    Report

    Report Number
    2648666-1998-00044
    Event Type
    Injury
    Date Received
    December 11, 1998
    Date of Event
    September 21, 1998
    Report Date
    November 13, 1998
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER A TOTAL KNEE, THE SURGICAL SITE BECAME INFECTED. THEY IDENTIFIED THE ORGANISM AS STAPHYLOCOCCUS SIMULANS. THE PATIENT WENT TO THE HOSPITAL TO HAVE THE WOUND SITE DRAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC BLOOD CONSERVATION KIT BOTTLE, COLLECTOR, VACUUM CAC STRYKER INSTRUMENTS 0215-416-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention