BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOWN

    MDR report key: 1891782 · Received October 5, 2010

    Report

    Report Number
    1891782
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FYA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    THE CUFF OF GOWN WAS NEARLY TORN OFF THE SLEEVE WHEN THE PRODUCT WAS OPENED. THE STAFF STATE THE GOWNS HAVE BEEN TEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOWN GOWN IN PACK FYA CARDINAL HEALTH SOP35KNBLZ *

    Patients

    Seq Age Sex Outcome Treatment
    1 *