BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVATEC LOOP OSTOMY ROD

    MDR report key: 599863 · Received May 2, 2005

    Report

    Report Number
    1049092-2005-00030
    Event Type
    Malfunction
    Date Received
    May 2, 2005
    Date of Event
    April 18, 2005
    Report Date
    May 2, 2005
    Manufacturer
    CONVATEC,
    Product Code
    EZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT OSTOMY SURGERY IN 2005. SIX DAYS LATER, THE NURSE REPORTED THAT DURING THE REMOVAL PROCEDURE OF THE CONVATEC LOOP OSTOMY ROD, THE OSTOMY ROD "BROKE". THE NURSE WAS ABLE TO RETRIEVE THE MISSING PIECE WHICH PREVENTED THE PATIENT FROM RETURNING BACK TO THE OR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other