inforMED
MalfunctionEZP

CONVATEC LOOP OSTOMY ROD

Received Apr 30, 2005 · Event occurred Mar 9, 1998

Report 1049092-2005-00012 · MDR key 599256

Device

Generic name

Ostomy Rod

Manufacturer

Convatec

Model number

NA

Catalog number

22355

Lot number

UNK

Product problems

  • Component Missing

Patient

UNKNOWN

  • Foreign body, removal of
  • Colostomy

Narrative

Description of Event or Problem

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.

Remedial action

  • Other