BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISPOSABLE VEIN STRIPPER

    MDR report key: 836699 · Received April 11, 2007

    Report

    Report Number
    1226348-2007-00101
    Event Type
    Injury
    Date Received
    April 11, 2007
    Date of Event
    November 23, 2006
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GAJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR HAS RECEIVED THE DEVICE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT A BRILLIANCE ARTIFICER WAS USED TO LOCALIZE THE PIECE OF THE PROBE THAT BROKE OFF IN THE CHANNEL NEAR THE THIGH. AN INCISION WAS MADE TO RETRIEVE THE PIECE OF THE PROBE. IN PROBING AND STRIPPING THE SAPHENOUS VEIN. THE PROBE BROKE OFF AT THE LEVEL OF THE INSERTION OF THE RETAINER WHERE IT INSERTS IN THE TRACTION DOME. AS A RESULT SURGERY WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN DISPOSABLE VEIN STRIPPER STRIPPER VEIN, DISPOSABLE GAJ CODMAN & SHURTLEFF, INC. NA MX457

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention