BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXI-TIP URETERAL CATHETER

    MDR report key: 2848417 · Received November 21, 2012

    Report

    Report Number
    1825146-2012-00028
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    September 20, 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 URETHRAL CATHETERS/(PRODUCT CODE GBL). FOR THIS REASON, OUR REPORT LISTS A URETERAL CATHETER AS THE COMPLAINT DEVICE. PRODUCT RETURN HAS BEEN REQUESTED. COOK WILL COMPLETE A FOLLOW UP REPORT AFTER ANY INVESTIGATION OF THE RETURN DEVICE, SHOULD THE USER FACILITY RETURN THE DEVICE.

    Description of Event or Problem · 1

    WHILE INSERTING A URETERAL STENT INTO THE CATHETER, IT WAS NOTED THAT THE TIP HAD BROKEN OFF IN THE BLADDER. A FLEXIBLE GRASPER WAS OBTAINED FROM CYSTO AND THE STENT TIP WAS REMOVED VERY EASILY WITHOUT ANY INJURY 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention