BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH, SURGIDAC

    MDR report key: 1960043 · Received December 30, 2010

    Report

    Report Number
    1960043
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    November 16, 2010
    Report Date
    December 30, 2010
    Manufacturer
    COVIDIEN
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDO STITCH BECAME DISLODGED IN ABDOMINAL WALL DURING PLACEMENT OF STITCH THROUGH THE RECTUS FASCIA AND WAS DISLODGED INTO THE FASCIAL LAYER AND WAS UNABLE TO BE RETRIEVED.HEALTH PROFESSIONAL'S IMPRESSION: RETAINED OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH, SURGIDAC SUTURE DEVICE, LOAD GAT COVIDIEN 173024 NOHO750

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR NO OTHER THERAPIES