BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOSTON SCIENTIFIC CORPORATION A00343

    MDR report key: 6707673 · Received July 11, 2017

    Report

    Report Number
    6707673
    Event Type
    Injury
    Date Received
    July 11, 2017
    Date of Event
    May 26, 2017
    Report Date
    June 29, 2017
    Product Code
    GBO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PHYSICIAN WAS ATTEMPTING TO REMOVE THE MALECOT NEPHROSTOMY TUBE 16F, IT TORE REQUIRING A RETURN TO SURGERY TO RETRIEVE THE OTHER PORTION OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485153 BOSTON SCIENTIFIC CORPORATION A00343 RE-ENTRY MALECOT NEPHROSTOMY CATHETER SET 011874 GBO M0064101050

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention