BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCKET IPC PLEURAL CAHETER

    MDR report key: 9249985 · Received October 28, 2019

    Report

    Report Number
    MW5090745
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    August 1, 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

    THE PLEURAL CATHETER FRACTURED UPON REMOVAL LEAVING PART OF IT IN THE PLEURAL SPACE, AN INCISION WAS REQUIRED TO REMOVE THE REMAINING PORTION FROM THE PLEURAL SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042062 ROCKET IPC PLEURAL CAHETER APPARATUS, SUNCTION, PATIENT CARE DWM ROCKET MEDICAL PLC R51400-16-PL 477903

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR