BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN DISPOS VEIN STRIP

    MDR report key: 805693 · Received January 16, 2007

    Report

    Report Number
    1226348-2007-00024
    Event Type
    Injury
    Date Received
    January 16, 2007
    Date of Event
    December 6, 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

    IT HAS BEEN COMMUNICATED BY THE AFFILIATE THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, SINCE A LOT NUMBER HAS BEEN PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE REVIEW WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF ANYTHING OTHERWISE IS NOTED, A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE DISTAL PART OF THE STRIPPER WHICH MAINTAINS THE OLIVE WAS DETACHED FROM THE CORD. THE SURGEON HAD TO MAKE AN INCISION TO REMOVE THE OLIVE AND REPEATE THE STRIPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN DISPOS VEIN STRIP STRIPPER, VEIN, DISPOSABLE GAJ CODMAN & SHURTLEFF, INC. NA MX468

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention