BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD

    MDR report key: 19237485 · Received May 3, 2024

    Report

    Report Number
    19237485
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    January 17, 2024
    Report Date
    April 24, 2024
    Manufacturer
    AVID MEDICAL, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    HAIR WAS FOUND ON THE NEEDLE MAT FOAM UNDER THE STICKY PORTION. HALYARD ORTHOPEDIC SURGICAL PROCEDURE KIT SAVED FOR EVALUATION AND GIVEN TO CENTRAL SUPPLY MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420100 HALYARD GENERAL SURGERY TRAY LRO AVID MEDICAL, INC. SOTJ40D_0001 647231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown