BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRIFLEX FEEDING TUBE

    MDR report key: 392132 · Received May 1, 2002

    Report

    Report Number
    1314412-2002-00005
    Event Type
    Malfunction
    Date Received
    May 1, 2002
    Report Date
    May 1, 2002
    Manufacturer
    THE KENDAL COMPANY
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS FITTED WITH AN ENTRIFLEX TUBE (18FR) FOR POST-OP DRAINAGE. IT WAS IMPOSSIBLE TO REMOVE THE GUIDE. THE TUBE WAS PULLED OUT, THE GUIDE REMOVED AND THE TUBE FITTED AGAIN ON PATIENT. SMALL INTESTINE PERFORATION ALLEGEDLY OCCURRED AT SOME POINT. MEDICAL INTERVENTION WAS REQUIRED. PATIENT IS FINE. COMPLAINT REPORTED TO UK OFFICE ON 04/2002. COMPLAINT REPORTED TO US OFFICE ON 04/2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRIFLEX FEEDING TUBE FEEDING TUBE FPD THE KENDAL COMPANY * U022201

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention