BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-LAYER AAMI 2

    MDR report key: 6102917 · Received November 15, 2016

    Report

    Report Number
    6102917
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    August 29, 2016
    Report Date
    August 31, 2016
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    OEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE NURSE WAS ATTEMPTING TO DON AN ISOLATION GOWN. THEY NOTED THE RIGHT ARM OF GOWN WHERE SLEEVE MEETS SHOULDER WAS SEWN CLOSED, SO THEY WERE UNABLE TO PLACE THEIR ARM IN THE SLEEVE OF THE GOWN. WE CHECKED SEVERAL OTHER GOWNS FROM THIS LOT AND THE SAME ISSUE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754621 TRI-LAYER AAMI 2 NON-SURGICAL ISOLATION GOWN OEA HALYARD HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1