BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCANLAN INTERNATIONAL, INC.

    MDR report key: 522090 · Received April 21, 2004

    Report

    Report Number
    2126670-2004-00001
    Event Type
    Injury
    Date Received
    April 21, 2004
    Date of Event
    March 9, 2004
    Report Date
    April 22, 2004
    Manufacturer
    SCANLAN INTL., INC.
    Product Code
    JOK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SCISSORS BLADE FRAGMENT BECAME DETATCHED DURING MITRAL VALVE PROCEDURE AND REMAINS IN PT. ADDITIONAL SURGICAL INTERVENTION INCLUDING REOPENING THE CHEST INCISION TO RETRIEVE THE FRAGMENT WAS NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCANLAN INTERNATIONAL, INC. SURGICAL SCISSORS JOK SCANLAN INTL., INC. 7007-222-1SC R91

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention