BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSOETM

    MDR report key: 16673099 · Received April 4, 2023

    Report

    Report Number
    16673099
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 23, 2023
    Report Date
    March 24, 2023
    Manufacturer
    ATTUNE MEDICAL
    Product Code
    PLA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ENTERAL PORT WITH TEAR AT BIFURCATION WITH COOLING LUMENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382498 ENSOETM ESOPHAGEAL THERMAL REGULATION AND GASTRIC SUCTIONING DEVICE PLA ATTUNE MEDICAL ECD04-A 199207722

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown