BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVATEC LOOP OSTOMY ROD

    MDR report key: 603095 · Received May 13, 2005

    Report

    Report Number
    1049092-2005-00031
    Event Type
    Malfunction
    Date Received
    May 13, 2005
    Date of Event
    April 29, 2004
    Report Date
    May 12, 2005
    Manufacturer
    CONVATEC
    Product Code
    EZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS CASE WAS DISCOVERED DURING THE ANALYSIS OF MALFUNCTION REPORT 1049092-2005-00030 WHICH WAS SUBMITTED IN 05/2005. THAT CASE MENTIONED THE OCCURRENCE OF THIS EVENT WHICH WAS NOT PREVIOUSLY REPORTED TO CONVATEC. NURSE STATED THIS EVENT OCCURRED "WITHIN THE PAST YEAR". THE SWIVEL TIP SEPARATED FROM THE ROD WHILE THE ROD WAS SUTURED IN PLACE. THE PT'S ABDOMEN HAD BECOME VERY DISTENDED AND THE ROD CAME APART. NURSE STATED THAT IT WAS NOT CONSIDERED AN ISSUE AT THE TIME AND, AS A RESULT, WAS NOT REPORTED TO CONVATEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVATEC LOOP OSTOMY ROD OSTOMY ROD EZP CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other