BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERITONEAL SHUNT CATHETER

    MDR report key: 33361 · Received June 11, 1996

    Report

    Report Number
    MW1009265
    Event Type
    Injury
    Date Received
    June 11, 1996
    Date of Event
    May 17, 1996
    Report Date
    May 30, 1996
    Manufacturer
    DENVER BIOMATERIALS, INC.
    Product Code
    KPM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH MULTIPLE MEDICAL PROBLEMS WHO HAD RECURRENT MASSIVE ASCITES DESPITE MAXIMAL MEDICAL TREATMENT. HAD A PERITONEAL VENOUS SHUNT PLACED ON 7/19/95, BUT EXPERIENCED PROBLEMS WITH IT NOT WORKING EFFECTIVELY. THE SHUNT WAS CLEANED AND REPOSITIONED (ADHESIONS AND CLOT NOTED) ON 3/28/96 WITH IMMEDIATE RELIEF. HOWEVER, IN MAY THE PT AGAIN HAD PROBLEMS WITH ASCITES INCREASING, SO ON 5/17/96 THE SURGEON PLACED A SECOND SHUNT. AGAIN, THE SURGEON FELT THIS WAS NOT A DEVICE PROBLEM AS SUCH, BUT MORE A PROBLEM DUE TO THE PT'S MULTIPLE MEDICAL CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERITONEAL SHUNT CATHETER PERITONEAL SHUNT CATHETER KPM DENVER BIOMATERIALS, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R