BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-TIP URETERAL CATHETER

    MDR report key: 2848265 · Received November 21, 2012

    Report

    Report Number
    1825146-2012-00029
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    September 13, 2012
    Report Date
    October 22, 2012
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    GBL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WE REQUESTED THE DEVICE FROM THE USER FACILITY. IF AND WHEN WE RECEIVE THE DEVICE WE WILL PERFORM OUR INVESTIGATION AND FILE A FOLLOW-UP REPORT WITH FDA WITH THE RESULTS OF THE INVESTIGATION. THE USER FACILITY REPORT THAT WAS SUBMITTED TO FDA LISTS THE COMPLAINT DEVICE AS A URETERAL STENT (PRODUCT CODE FAD). THE LOT NUMBERS ON THE SAME REPORT, HOWEVER, CORRESPOND TO URETERAL CATHETERS (PRODUCT CODE GBL). FOR THIS REASON, OUR REPORT LISTS A URETERAL CATHETER AS THE COMPLAINT DEVICE. UNSURE OF PRODUCT RETURN.

    Description of Event or Problem · 1

    THE TIP OF THE FLEXI-TIP URETERAL CATHETER BROKE OFF IN THE PT DURING THE PROCEDURE. THE TIP WAS REMOVED AND THERE WAS NO HARM TO THE PT. THE TIP OF THE CATHETER WAS REMOVED SUCCESSFULLY WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXI-TIP URETERAL CATHETER GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY GBL COOK UROLOGICAL, INC. NA U2224486

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention