BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETHRAL FILIFORM WITH STRAIGHT TIP

    MDR report key: 285299 · Received July 7, 2000

    Report

    Report Number
    2429473-2000-00057
    Event Type
    Malfunction
    Date Received
    July 7, 2000
    Date of Event
    June 28, 2000
    Report Date
    July 7, 2000
    Manufacturer
    RUSCH, INC.
    Product Code
    FAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE FILIFORM "CURLS UP" WHEN THE DOCTOR ATTEMPTS TO INTRODUCE THE FILIFORM INTO THE PT, THUS PREVENTING INSERTION. A DIFFERENT SIZE FILIFORM WAS THEN EMPLOYED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETHRAL FILIFORM WITH STRAIGHT TIP FILIFORM WITH STRAIGHT TIP FAX RUSCH, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN