BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEOSTOMY KIT

    MDR report key: 19237524 · Received May 3, 2024

    Report

    Report Number
    19237524
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    February 24, 2024
    Report Date
    March 8, 2024
    Manufacturer
    MEDICAL ACTION INDUSTRIES, INC.
    Product Code
    OGW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHEN GOING TO GRAB 3.0 BONE FROM THE RESPIRATORY CART FOR A PATIENT, IT WAS NOTICED THAT THE BONE DID NOT HAVE A HOLE DRILLED INTO IT. THE BONE WAS IN AN UNOPENED STERILE PACKAGE THAT WAS LABELED 3.0 AT THE BOTTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420110 TRACHEOSTOMY KIT OGW MEDICAL ACTION INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown