BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK

    MDR report key: 15380647 · Received September 7, 2022

    Report

    Report Number
    MW5111927
    Event Type
    Injury
    Date Received
    September 7, 2022
    Date of Event
    August 18, 2022
    Report Date
    September 6, 2022
    Manufacturer
    CORPAK MED SYSTEMS / AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NL
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CORTRAK ENTERAL ACCESS SYSTEM WAS PLACED IN LEFT LUNG BY ACCIDENT. COMPLICATION CAUSED PNEUMOTHORAX OF THE LEFT LUNG. PATIENT WAS HOSPITALIZED ON (B)(6) 2022 AND LEFT THE HOSPITAL ON (B)(6) 2022. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805328 CORTRAK TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CORPAK MED SYSTEMS / AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Life Threatening| H