BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSS FLEXIFLO LAP G KIT

    MDR report key: 414288 · Received August 29, 2002

    Report

    Report Number
    MW1026026
    Event Type
    Injury
    Date Received
    August 29, 2002
    Date of Event
    August 21, 2002
    Report Date
    August 29, 2002
    Manufacturer
    ROSS LABORATORIES
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED WITH LARYNGEAL CANCER FOR A CORPAK NG, G-TUBE PLACEMENT AND LARYNGECTOMY. PT HAS DYSPHAGIA, WEIGHT LOSS OF 24-30 LBS THE PAST TWO YEARS AND FRANK ASPIRATION. G-TUBE WAS PLACED LAPAROSCOPICALLY AND PT WAS TAKEN TO ICU. G-TUBE WAS DISLODGED. TUBE WAS CHECKED. THE BALLOON APPEARED TO BE PATENT BUT UPON REMOVAL IT WAS DEFLATED. PT WAS NOT COMPLAINING OF ANY PERITONEAL SIGNS SO THEY WERE KEPT NPO AND TAKEN BACK TO THE OR FOR LAPAROSCOPIC REPLACEMENT OF THE G TUBE. SURGEON INFLATED THE TUBE PREOPERATIVELY WITH 15 CC SALINE AND VISUALLY CONFIRMED THAT IT WAS WITHIN THE STOMACH. OUTER FLANGE WAS ASSURED TO BE AT 3 CM. TWO 3-0 SUTURES WERE PLACED TO ASSURE THAT THE TUBE COULD NOT BE DISLODGED. PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PT IS STILL HOSPITALIZED FOLLOWING LARYNGECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROSS FLEXIFLO LAP G KIT GASTROSTOMY TUBE KNT ROSS LABORATORIES 18 FRENCH LAP GASTROSTOMY KIT *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R