BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD

    MDR report key: 19350722 · Received May 20, 2024

    Report

    Report Number
    19350722
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    February 2, 2024
    Report Date
    February 22, 2024
    Manufacturer
    O & M HALYARD, INC.
    Product Code
    FYA
    UDI-DI
    10680651446746
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN UNFOLDING AND OPENING THE STERILE GOWN A PIECE OF BLUE STICKY TAPE WAS FOUND INSIDE THE STERILE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605627 HALYARD GOWN, SURGICAL FYA O & M HALYARD, INC. 44674 AH3191TO7 10680651446746

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown