BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANASTOCLIP CLIP APPLIER

    MDR report key: 769464 · Received October 12, 2006

    Report

    Report Number
    MW1040670
    Event Type
    Injury
    Date Received
    October 12, 2006
    Date of Event
    August 1, 2006
    Report Date
    September 25, 2006
    Manufacturer
    *
    Product Code
    GDO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT BLEEDING OCCURRED IN THE PT TWO WEEKS AFTER SURGERY. THE PT HAD BEEN BROUGHT IN FOR EMERGENCY SURGERY TO STOP THE BLEEDING. THE BLEEDING WAS AT THE ANASTOMOSIS SITE. THE PT IS ALIVE. DEVICE WAS NOT RETURNED FOR EVALUATION. LEMAITRE REPRESENTATIVE SPOKE WITH THE PHYSICIAN AFTER THE INCIDENT. THE PHYSICIAN NOTED THAT HE MAY HAVE HAD SOME ISSUES WITH SPACING OF THE CLIPS AND HOW TO DEAL WITH THE BLEEDING WHEN THE ANASTOMOSIS WAS FIRST OPENNED. LEMAITRE REP SUGGESTED TO THE PHYSICIAN TO ATTEND TRAINING SESSIONS THAT ARE OFFERED BY LEMAITRE VASCULAR, INC. PHYSICIAN AGREED TO ATTEND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANASTOCLIP CLIP APPLIER CLIP APPLIER GDO * NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization