BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENVER ASCITES SHUNT

    MDR report key: 41052 · Received September 12, 1996

    Report

    Report Number
    1717671-1996-00001
    Event Type
    Malfunction
    Date Received
    September 12, 1996
    Date of Event
    August 1, 1996
    Report Date
    September 12, 1996
    Manufacturer
    DENVER BIOMATERIALS, INC.
    Product Code
    KPM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT RECEIVED AN ASCITES SHUNT, CATALOG #42-4002, ON 7/25/95. RECENTLY THE PT'S ASCITES RETURNED. THE SURGEON OPERATED TO REPLACE THE OCCLUDED PORTION OF THE SHUNT AND UPON ENTRY COULD NOT FIND THE PERITONEAL CATHETER. FURTHER EXAMINATION SHOWED THAT THE PERITONEAL CATHETER HAD SEVERED FROM THE SHUNT AND WAS INSIDE THE PERITONEAL CAVITY. THE SURGEON PERFORMED LAPAROSCOPIC SURGERY TO RETRIEVE THE CATHETER, AND IMPLANTED A NEW SHUNT. THERE WERE NO PT INJURIES ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENVER ASCITES SHUNT Implant PERITONEO-VENOUS SHUNT KPM DENVER BIOMATERIALS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization