BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTER-THOMASON

    MDR report key: 6232587 · Received January 9, 2017

    Report

    Report Number
    6232587
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Date of Event
    December 20, 2016
    Report Date
    December 21, 2016
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS CLOSING THE PORT SITE WITH THE CARTER- THOMASON CLOSURE DEVICE AND THE DEVICE FELL APART. ALL PIECES WERE RETRIEVED. THERE WAS NO HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL; PLASTIC SURGERY, CARTER-THOMASON (PER SITE REPORTER): REPRESENTATIVE TOOK LOT# INFORMATION BACK TO THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16884 CARTER-THOMASON LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COOPERSURGICAL, INC. CTI-512N 207298

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR