BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSS 18 FR. G-TUBE FLAX & FLOW

    MDR report key: 353419 · Received September 24, 2001

    Report

    Report Number
    MW1022925
    Event Type
    Malfunction
    Date Received
    September 24, 2001
    Date of Event
    August 14, 2001
    Report Date
    September 21, 2001
    Manufacturer
    ROSS PRODUCTS DIV. ABBOTT LABORATORIES
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WITH A LARGE PARAESOPHAGEAL HERNIA WAS SCHEDULED FOR LAPAROSCOPIC GASTROSTOMY TUBE PLACEMENT AND GASTROPEXY. POSTOPERATIVELY, WHILE THE PT WAS IN THE RECOVERY ROOM, THE GASTROSTOMY TUBE ACCIDENTALLY FELL OUT. PHYSICIAN'S PROGRESS NOTE STATES THAT BALLOON DEFLATED, WAS CHECKED WITH 20 CC NORMAL SALINE AND HAD A VERY SMALL TEAR. PT WAS TAKEN BACK TO O.R. AND HAD THE GASTROSTOMY TUBE REPLACED VIA THE LAPAROSCOPIC TECHNIQUE THROUGH THE SAME INCISIONS. PT TOLERATED BOTH PROCEDURES WELL. THERE WAS NO SIGN OF LEAKAGE FROM THE GASTROSTOMY TUBE SITE. PT'S GENERAL POST-OP COURSE WAS SLOW IMPROVEMENT OF STRENGTH AND ORAL INTAKE, WHICH RETURNED ALMOST TO PREVIOUS PRE-HOSP CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43231 ROSS 18 FR. G-TUBE FLAX & FLOW GASTROSTOMY TUBE KNT ROSS PRODUCTS DIV. ABBOTT LABORATORIES ROSS 18 FR. G-TUBE 15 CC *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other