BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIFLO GASTROSTOMY TUBE

    MDR report key: 528173 · Received June 1, 2004

    Report

    Report Number
    1528738-2004-00031
    Event Type
    Injury
    Date Received
    June 1, 2004
    Date of Event
    May 4, 2004
    Report Date
    May 4, 2004
    Manufacturer
    ROSS PRODUCTS DIVISION/ABBOTT LABORATORIES
    Product Code
    KNT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAS HAD 4 TUBES PLACED SINCE JANUARY, 2004, AND ALL HAVE LEAKED. PT HAS STOMA SITE REDNESS WHICH WAS TREATED WITH 2 RX TOPICAL MEDICATIONS. ONE PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFLO GASTROSTOMY TUBE 78 KNT TUBES, GASTROINTESTINAL AND ACCESSORIES KNT ROSS PRODUCTS DIVISION/ABBOTT LABORATORIES 51364 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention