BEUDAMED
    FDA Adverse Event Other Summary report: N

    PEDS UROLOGY CUSTOM PACK

    MDR report key: 20724807 · Received November 18, 2024

    Report

    Report Number
    MW5162647
    Event Type
    Other
    Date Received
    November 18, 2024
    Date of Event
    November 11, 2024
    Report Date
    November 15, 2024
    Manufacturer
    OWENS AND MINOR DISTRIBUTION INC. OM44
    Product Code
    LRO
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    UPON OPENING THE PEDS UROLOGY CUSTOM PACK, UNKNOWN BLACK SPECS WERE DISCOVERED ON THE TABLE COVER AND LIGHT HANDLE. THE ENTIRE PACK WAS IMMEDIATELY TAKEN OFF THE FIELD. LOT# 1621342.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2008417 PEDS UROLOGY CUSTOM PACK GENERAL SURGERY TRAY LRO OWENS AND MINOR DISTRIBUTION INC. OM44 1621342

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Other