BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL ACTION INDUSTRIES

    MDR report key: 9568703 · Received January 9, 2020

    Report

    Report Number
    9568703
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    Date of Event
    November 14, 2019
    Report Date
    December 5, 2019
    Manufacturer
    MEDICAL ACTION INDUSTRIES INC.
    Product Code
    NXA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING TRACH CARE, TRACH CARE TRAY OPENED AND FOUND IT FILLED WITH RUST AND MOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35602 MEDICAL ACTION INDUSTRIES TRACHEOTOMY CARE KIT NXA MEDICAL ACTION INDUSTRIES INC. 75378 259371

    Patients

    Seq Age Sex Outcome Treatment
    1