BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GASTROJEJUNAL FEEDING TUBE

    MDR report key: 8163825 · Received December 14, 2018

    Report

    Report Number
    9611594-2018-00228
    Event Type
    Injury
    Date Received
    December 14, 2018
    Report Date
    November 20, 2018
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO CODE: REFLUX. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 12-DEC-2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING, "I CURRENTLY HAVE A TYPICAL JEJUNOSTOMY TUBE. IT IS PERMANENT AND IS HELD IN PLACE BY AN EXTERNAL DRAIN FIX DRESSING. I AM FRUSTRATED WITH THE LOOSE TUBE AS I AM AN ACTIVE PERSON AND WOULD LIKE ONE THAT IS FIXED. HOWEVER, I USED TO HAVE A GJ TUBE BUT THE TUBE KEPT RECOILING BACK INTO MY STOMACH, CAUSING REFLUX AND MORE ASPIRATION PNEUMONIAS - HENCE THE DIRECT J-TUBE NOW." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005713 UNKNOWN GASTROJEJUNAL FEEDING TUBE DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other