BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISPOSABLE VEIN STRIPPER

    MDR report key: 487948 · Received October 8, 2003

    Report

    Report Number
    1226348-2003-00230
    Event Type
    Injury
    Date Received
    October 8, 2003
    Date of Event
    July 22, 2003
    Report Date
    September 24, 2003
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GAJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE PT HAD A VEIN STRIPPED IN JULY 2003. THE PROCEDURE WENT WELL AND THE VEINS WERE REMOVED AND WOUNDS WERE SUTURED CLOSED. THE PT COMPLAINED OF A LUMP IN THE LEG. THE PT WAS ADMITTED IN SEPTEMBER 2003 AND THE FORIEGN BODY WAS REMOVED. THE FOREIGN BODY WAS THE SMALL OLIVE WHICH WAS ATTACHED ONTO THE STRIPPER CABLE. THE OLIVE HAD APPARENTLY SEPARATED FROM THE CABLE DURING THE ORIGINAL VEIN STRIPPING PROCEDURE. NO PRODUCT IS BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN DISPOSABLE VEIN STRIPPER STRIPPER, VEIN, DISPOSABLE GAJ CODMAN & SHURTLEFF, INC. NA CV512

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention