BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-T II PORT CLOSURE, 10/15(MM)

    MDR report key: 3021027 · Received March 20, 2013

    Report

    Report Number
    1216677-2013-00006
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED C-T II PORT CLOSURE, 10/15(MM) IS STILL UNDER INVESTIGATION BY OUR ENGINEERING DEPARTMENT. (B)(4).

    Description of Event or Problem · 1

    THE DOCTOR MADE A PASS WITH THE C-T II NEEDLE AND WHEN THE NEEDLE/SUTURE EXITED THE PILOT GUIDE, A SMALL SLIVER OF PLASTIC WAS PUSHED INTO THE ABDOMINAL CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115606 C-T II PORT CLOSURE, 10/15(MM) NONE HET COOPERSURGICAL, INC. 135861

    Patients

    Seq Age Sex Outcome Treatment
    1