BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN-END URETERAL CATHETER

    MDR report key: 2792340 · Received October 12, 2012

    Report

    Report Number
    1825146-2012-00023
    Event Type
    Injury
    Date Received
    October 12, 2012
    Report Date
    September 14, 2012
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    GBL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEWED THE DEVICE HISTORY RECORD FOR THE COMPLAINT DEVICE. THE FACILITY DID NOT RETURN THE COMPLAINT DEVICE, THUS COOK COULD NOT PERFORM A PHYSICAL EXAMINATION OF THE DEVICE. COOK REVIEWED THE WORKORDER OF THE COMPLAINT DEVICE'S LOT NUMBER; NO ISSUES WERE FOUND DURING THE MANUFACTURING OR INSPECTION OF THE COMPLAINT DEVICE.

    Description of Event or Problem · 1

    THE OPEN-END URETERAL CATHETER HAD BEEN IN PLACE IN THE PATIENTS BLADDER FOR LESS THAN 5 MINUTES WHEN THE CATHETER BROKE INTO SEVERAL PIECES. ALL PIECES WERE RETRIEVED AND ACCOUNTED FOR POST-OP USING CYSTOSCOPY GRASPING FORCEPS. THERE WAS NO HARM TO THE PATIENT. PER THE REPORTER, PATIENT CONDITION IS NONCONTRIBUTORY SINCE THERE WAS NO HARM FROM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPEN-END URETERAL CATHETER GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY GBL COOK UROLOGICAL, INC. NA U2219202

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention