BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRYKER NEPTUNE 2 ULTRA WASTE MANAGEMENT DEVICE SYSTEM

    MDR report key: 2837516 · Received November 13, 2012

    Report

    Report Number
    MW5027653
    Event Type
    Death
    Date Received
    November 13, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 13, 2012
    Manufacturer
    STRYKER
    Product Code
    FYD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT A THORACOTOMY PROCEDURE. THE CHEST TUBE WAS INADVERTENTLY ATTACHED TO THE STRYKER NEPTUNE 2 ULTRA INSTEAD OF THE PLEUROVAC SYSTEM CAUSING MASSIVE BLEEDING AND THE PT EXPIRED. REASON FOR USE: RIGHT LUNG MASS S/P THORACOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER NEPTUNE 2 ULTRA WASTE MANAGEMENT DEVICE SYSTEM NEPTUNE FYD STRYKER 1106101163

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death