BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN-END FLEXI-TIP URETERAL CATHETER

    MDR report key: 1924858 · Received December 7, 2010

    Report

    Report Number
    1825146-2010-00053
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 8, 2010
    Report Date
    December 3, 2010
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    GBL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED FOR EVAL, UPON RECEIPT OF THE DEVICE, A REPORT WILL BE COMPLETED. THE NURSE WAS CONTACTED FOR ADDITIONAL INFO CONCERNING THE EVENTS IN THE PROCEDURE NOTING A CYSTOSCOPY AND STENT PLACEMENT WAS PERFORMED. AS INDICATED BY THE NURSE, THE PHYSICIAN IDENTIFIED A PIECE OF PLASTIC FLOATING IN THE BLADDER AND EASILY REMOVED IT NOTING, NO ADDITIONAL PROCEDURES WERE NEEDED, AND THE PT WAS RELEASED IN STABLE CONDITION.

    Description of Event or Problem · 1

    WE USED A POLLACK OPEN-END FLEXI-TIP URETERAL CATHETER TODAY ON A PT THAT A PIECE CAME OFF THE CATHETER WHILE IN THE PT. DR (B)(6) WAS ABLE TO RETRIEVE THE PIECE. NO HARM REPORTED. THE PT WAS RELEASED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPEN-END FLEXI-TIP URETERAL CATHETER GBL CATHETER, URETERAL, GENERAL AND PLASTIC SURGERY GBL COOK UROLOGICAL, INC. NA U1928647

    Patients

    Seq Age Sex Outcome Treatment
    1