BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGION

    MDR report key: 1840040 · Received September 21, 2010

    Report

    Report Number
    1020279-2010-00267
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 20, 2010
    Report Date
    October 7, 2010
    Manufacturer
    SMITH & NEPHEWM, INC. ORTHOPAEDIC DIVISION
    Product Code
    EKD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT SURGERY TIME WAS EXTENDED DUE TO ISSUES WITH MAKING THE ANTERIOR CUTS DURING THE SURGERY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT FALSE NEGATIVE REACTIONS WERE OBSERVED WITH A PATIENT SAMPLE THAT RESULTED AS TYPE O IN THE FORWARD GROUPING BUT RESULTED AS TYPE A IN THE REVERSE GROUPING. TESTING WAS REPEATED WITH THE SAME RESULTS. PER INTERNAL POLICY, THE SAMPLE WAS SENT TO THE REFERENCE LAB FOR CONFIRMATION USING TUBE METHOD. THE REFERENCE LAB REPORTED THE SAMPLE TO BE GROUP O, WITH NO ISSUES. DAILY QC WAS ACCEPTABLE. ALL LISTED PRODUCTS HAVE BEEN STORED AS PER PACKAGE INSERTS AND APPEAR NORMAL BEFORE USE. ALL OTHER SAMPLES TESTED HAVE RESULTED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGION VISIONAIRE DSTL FEM CUTTING BLOCK EKD SMITH & NEPHEWM, INC. ORTHOPAEDIC DIVISION PM012139V1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization