BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHISTLE TIP URETERAL CATHETER

    MDR report key: 1696663 · Received May 21, 2010

    Report

    Report Number
    1825146-2010-00017
    Event Type
    Injury
    Date Received
    May 21, 2010
    Date of Event
    April 22, 2010
    Report Date
    April 22, 2010
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    EYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED CATHETER WAS RECEIVED IN TWO PIECES IN A SPECIMEN JAR. THE DISTAL SEGMENT MEASURES 17.4CM AND THE PROXIMAL SEGMENT MEASURES 54.9CM AND THE TWO PIECES ARE MATING FRACTURES NOTING THE ENTIRE CATHETER WAS RETURNED. THE SEPARATION HAS THE APPEARANCE OF BEING CAUGHT ON AN INSTRUMENT OF UNDETERMINED ORIGIN CUTTING THE CATHETER.

    Description of Event or Problem · 1

    UPON REMOVING THE CATHETER FOLLOWING THE PROCEDURE, THE CATHETER BROKE OFF INSIDE THE PT. THE SEGMENT WAS REMOVED FROM THE URETER DURING THE SAME PROCEDURE. INITIAL INFO INDICATES SURGICAL PROCEDURE TO REMOVE. ADDITIONAL INFO CONCERNING THE INCIDENT AS WELL AS REMOVAL HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHISTLE TIP URETERAL CATHETER EYB CATHETER, URETERAL, GASTRO-UROLOGY EYB COOK UROLOGICAL, INC. NA U1766282

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention