BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETHRAL FOLLOWER

    MDR report key: 294625 · Received September 5, 2000

    Report

    Report Number
    2429473-2000-00078
    Event Type
    Injury
    Date Received
    September 5, 2000
    Date of Event
    August 28, 2000
    Report Date
    September 5, 2000
    Manufacturer
    RUSCH, INC.
    Product Code
    FAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE PHILLIPS CATHETER FOLLOWER CAME OFF IN THE PATIENT'S URETHRA, LEAVING THE FILIFORM AND FOLLOWER TIP ON THE URETHRA ONCE THE FOLLOWER WAS WITHDRAWN. THE DR USED GRASPERS TO REMOVE THE FOLLOWER TIP AND FILIFORM. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETHRAL FOLLOWER URETHRAL FOLLOWER FAX RUSCH, INC. NA 97001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention