BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PLASTICS EYE PACK

    MDR report key: 21026914 · Received December 26, 2024

    Report

    Report Number
    MW5163981
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    December 20, 2024
    Report Date
    December 23, 2024
    Manufacturer
    OWENS AND MINOR/ O&M HALYARD, INC./ AMERICAN CONTRACT SYSTEMS.
    Product Code
    OJK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DEBRIS DISCOVERED IN O&M PLASTICS EYE PACK AS THE PATIENT WAS BROUGHT INTO THE OR (OPERATION ROOM). SURGEON AND COORDINATOR NOTIFIED. NEW BACK TABLE SET UP WHILE PATIENT WAS IN THE OPERATION ROOM. PHOTOS OF DEBRIS WILL BE PROVIDED TO OR LEADERSHIP. PLASTIC EYE PACK; RYEP01-02, LOT #: 1624280.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2429193 CUSTOM PLASTICS EYE PACK EYE TRAY OJK OWENS AND MINOR/ O&M HALYARD, INC./ AMERICAN CONTRACT SYSTEMS. 1624280

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other