BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVATEC LOOP OSTOMY ROD

    MDR report key: 584549 · Received March 17, 2005

    Report

    Report Number
    1049092-2005-00008
    Event Type
    Malfunction
    Date Received
    March 17, 2005
    Date of Event
    February 17, 2005
    Report Date
    March 17, 2005
    Manufacturer
    CONVATEC
    Product Code
    EZP
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE RISK MANAGER REPORTS DURING TRANSVERSE COLOSTOMY PROCEDURE IN 2005, THE CONVATEC LOOP OSTOMY ROD BROKE INTO TWO PIECES. THE SURGEON WAS INSERTING THE LOOP AT THE TIME IT BROKE. HE WAS ABLE TO REMOVE THE PIECES WITH NO ADVERSE AFFECT TO THE PATIENT AND REPLACED IT WITH ANOTHER ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVATEC LOOP OSTOMY ROD OSTOMY ROD EZP CONVATEC * 2D53535

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN