BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CORTRAK2 TUBE

    MDR report key: 7964619 · Received October 15, 2018

    Report

    Report Number
    9611594-2018-00187
    Event Type
    Injury
    Date Received
    October 15, 2018
    Report Date
    September 26, 2018
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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-OCT-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

    IT WAS REPORTED THAT DURING FLUOROSCOPY PLACEMENT THE CORTRAK2 TUBE PERFORATED THE PATIENT'S BOWEL. THE CORTRAK-2 ENTERAL ACCESS SYSTEM WAS NOT USED FOR PLACEMENT OF THE DEVICE. ADDITIONAL INFORMATION RECEIVED 26-SEP-2018 STATED THE INCIDENT OCCURRED IN (B)(6) 2018. THE USER FACILITY NOTED THE PATIENT PRESENTED WITH FEEDING INTOLERANCE AND A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED BOWEL PERFORATION. AN EXPLORATORY LAPAROSCOPY WITH REPAIR WAS PERFORMED. THE PATIENT'S STATUS WAS REPORTED TO BE STABLE. THERE WAS NO ADDITIONAL INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806911 UNKNOWN CORTRAK2 TUBE DH CORTRAK DISPOSABLES KNT AVANOS MEDICAL INC. UNKNOWN CORTRAK2 TUBE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention