BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVATEC LOOP OSTOMY ROD

    MDR report key: 599256 · Received April 30, 2005

    Report

    Report Number
    1049092-2005-00012
    Event Type
    Malfunction
    Date Received
    April 30, 2005
    Date of Event
    March 9, 1998
    Report Date
    April 29, 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

    CONVATEC WAS NOTIFIED BY A CLINICIAN THAT A LOOP OSTOMY ROD WAS USED ON A PT AND WAS REMOVED 7 DAYS POST-OP. THE NURSE WAS ABLE TO UNLOCK THE MECHANISM EASILY BUT WHEN THE ROD WAS REMOVED THE TIP WAS MISSING. THE PT'S PHYSICIAN CHOSE NOT TO PROBE FOR THE MISSING PIECE. THE PT WAS NOT INJURED IN ANY WAY DURING THE REMOVAL OF THE ROD. THE PT WAS DISCHARGED. CONVATEC FOLLOWED UP WITH THE NURSE AND DR TO CONFIRM PT HAD NOT SUFFERED ANY INJURIES; THIS WAS CONFIRMED. 6/1998 - CONVATEC WAS NOTIFIED THAT PT RETURNED TO THE HOSP FOR CLOSURE OF THE COLOSTOMY. DURING THE CLOSURE SURGERY THE MISSING PIECE OF THE LOOP OSTOMY ROD WAS FOUND. IT WAS REMOVED AND THE PT SUFFERED NO ADVERSE EFFECTS.

    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 PREDNISONE, OCT SUPPLEMENTS