BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-Z COIL SPECIAL (OZ C CA2)

    MDR report key: 628748 · Received August 22, 2005

    Report

    Report Number
    1317749-2005-00035
    Event Type
    Malfunction
    Date Received
    August 22, 2005
    Date of Event
    May 19, 2005
    Report Date
    August 5, 2005
    Manufacturer
    TYCO/KENDALL HEALTHCARE
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER HAD A PROBLEM WITH THE O-Z DIALYSIS CATHETER. FROM 2005 TO THE 6TH DAY THE PATIENT WAS HOSPITALIZED BECAUSE OF A PERITONITIS AND FLUID LEAKAGE AT THE CATHETER EXIT SITE. IN ABOUT TWO WEEKS LATER, THE PATIENT WAS RE-HOSPITALIZED BECAUSE OF A SEVERE PERITONITIS. IN ABOUT 2 WEEKS LATER THE CATHETER WAS REMOVED AND TUBING DEFECT OF THE CATHETER WAS NOTICED. DURING THE PROCEDURE ON THAT DAY, A NEW CATHETER WAS IMPLANTED AND THE PATIENT STARTED PERITONEAL DIALYSIS AGAIN IN A WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O-Z COIL SPECIAL (OZ C CA2) DIALYSIS CATHETER FJS TYCO/KENDALL HEALTHCARE 8888425710 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization