BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM GENERAL ORTHO PACK

    MDR report key: 20578075 · Received October 30, 2024

    Report

    Report Number
    MW5161942
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 3, 2024
    Report Date
    October 25, 2024
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    HALYARD CUSTOM GENERAL ORTHO PACK (LOT# 1606581) HAD A HOLE ON THE UNDER SIDE OF THE STERILE BLUE WRAPPING. THIS WAS DISCOVERED PRIOR TO THE PATIENT BEING BROUGHT INTO THE OPERATING ROOM. TABLE/SUPPLIES HAD TO BE TORN DOWN AND RE-SET UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065642 CUSTOM GENERAL ORTHO PACK GENERAL SURGERY TRAY LRO O&M HALYARD, INC. 1606581

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Other