BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCKET IPC PLEURAL CATHETER

    MDR report key: 9249975 · Received October 28, 2019

    Report

    Report Number
    MW5090744
    Event Type
    Injury
    Date Received
    October 28, 2019
    Date of Event
    September 10, 2019
    Report Date
    October 22, 2019
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    DWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON ATTEMPTED REMOVAL OF THE PLEURAL CATHETER, SIGNIFICANT ADHESIONS WERE NOTED AND COULD NOT BE REMOVED. EXTENSIVE DISSECTION WAS REQUIRED TO REMOVE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042080 ROCKET IPC PLEURAL CATHETER APPARATUS, SUCTION, PATIENT CARE DWM ROCKET MEDICAL PLC R51400-36-PL 477903

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention