BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISPOSABLE VEIN STRIPPER

    MDR report key: 860388 · Received June 5, 2007

    Report

    Report Number
    1226348-2007-00159
    Event Type
    Injury
    Date Received
    June 5, 2007
    Date of Event
    May 3, 2007
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GAJ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED, A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THAN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT, THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE END PART OF THE STRIPPER CABLE HAS DISCONNECTED TWICE. THE OLIVE HAS DETACHED FROM THE CABLE AND REMAINED IN THE PATIENT'S LEG. AS A RESULT SURGERY WAS DELAYED AND INCISION WAS MADE TO REMOVE THE OLIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN DISPOSABLE VEIN STRIPPER STRIPPER, VEIN, DISPOSABLE GAJ CODMAN & SHURTLEFF, INC. NA LY630

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention