MalfunctionEZP
CONVATEC LOOP OSTOMY ROD
Received Jul 22, 2005 · Event occurred Jun 20, 2005
Report 1049092-2005-00042 · MDR key 720249
Product problems
- Detachment Of Device Component
- Device Or Device Fragments Location Unknown
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
"IT IS A DETACHMENT OF THE SWIVEL AND (REPORTED BY SURGEON BECAUSE HE DID NOT FIND THIS SMALL PART OF THE LOOP WHEN HE EXAMINED THE PATIENT.) AND FOR INFORMATION, THE LOOP WAS USED WITH THE SYSTEM EASYFLEX 70 AND NOT SUTURED."
Remedial action
- Other