BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CYSTOMSTOMY CATHETER

    MDR report key: 213168 · Received February 23, 1999

    Report

    Report Number
    1825146-1999-00002
    Event Type
    Injury
    Date Received
    February 23, 1999
    Date of Event
    January 29, 1999
    Report Date
    February 23, 1999
    Manufacturer
    COOK OB/GYN
    Product Code
    KOB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS OPERATED ON FOR PROLAPSE OF THE BLADDER AND RECTUM. THE DOCTOR PUT A HOLE IN THE POSTERIOR SIDE OF THE BLADDER. A UROLOGIST WAS CALLED IN TO REPAIR THE BACK SIDE OF THE BLADDER BEFORE THEY COULD RELEASE THE PT FROM THE OPERATING ROOM. THE TROCAR WAS MUCH LARGER THAN USUAL. THE PT IS RECOVERING WITH NO ADVERSE COMPLICATIONS OCCURRING DUE TO THE ADDITIONAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CYSTOMSTOMY CATHETER Implant CATHETER, SUPRAPUBIC KOB COOK OB/GYN NA 527129

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention