BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL ACTION INDUSTRIES

    MDR report key: 7439477 · Received April 18, 2018

    Report

    Report Number
    7439477
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    April 5, 2018
    Report Date
    April 6, 2018
    Manufacturer
    MEDICAL ACTION INDUSTRIES INC.
    Product Code
    NXA
    UDI-DI
    10809160022221
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN NEW TRACH CARE TRAY WAS OPENED, THERE IS BROWN SUBSTANCE ON THE CONTENTS OF THE PACKAGE. THE CONTENTS APPEAR DIRTY. THIS WAS NOT UTILIZED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281992 MEDICAL ACTION INDUSTRIES TRACHEOTOMY CARE KIT NXA MEDICAL ACTION INDUSTRIES INC. 75378 239123 10809160022221

    Patients

    Seq Age Sex Outcome Treatment
    1