OtherFCE
ENEMA BAG
Received Jun 4, 2013 · Event occurred May 19, 2013
Report 9612030-2013-00017 · MDR key 3159312
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
38 YR
- Discomfort
- Foreign Body In Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH AN ENEMA BAG. THE CUSTOMER REPORTS THE NURSE ACCIDENTALLY DID NOT TAKE OFF THE BLUE CAP ON THE TAP WATER ENEMA AND THE BLUE PIECE ENDED UP BEING LODGED IN THE PATIENTS COLON. THE FACILITY STATED THE PATIENT UNDERWENT A FLEXIBLE SIGMOIDOSCOPY (FLEX SIG) PROCEDURE TO REMOVE THE BLUE PIECE. THE PATIENT IS STATED AS STABLE AND HAS BEEN DISCHARGED.
Additional Manufacturer Narrative
SUBMIT DATE ON: 06/03/2013. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.