BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 11796668 · Received May 10, 2021

    Report

    Report Number
    11796668
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 28, 2021
    Report Date
    April 28, 2021
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OJH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A HAIR WAS FOUND IN THE BOTTOM OF THE STERILE BASIN IN A CUSTOM TOTAL JOINT PACK. THE STERILE SET UP WAS DISCARDED AND A NEW PACK WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693066 CARDINAL HEALTH ORTHOPEDIC TRAY OJH CARDINAL HEALTH 200, LLC SOP12TJ38D 571480

    Patients

    Seq Age Sex Outcome Treatment
    1