BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN

    MDR report key: 19557126 · Received June 18, 2024

    Report

    Report Number
    19557126
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 15, 2024
    Report Date
    May 29, 2024
    Manufacturer
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION
    Product Code
    OJG
    UDI-DI
    10381780520375
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CAP BREAKAGE FROM EVD (EXTERNAL VENTRICULAR DRAINAGE) SYSTEM RESULTING IN PNEUMOCEPHALUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2322190 CODMAN NEUROLOGICAL TRAY OJG INTEGRA LIFESCIENCES PRODUCTION CORPORATION 826614 10381780520375

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H