FDA Adverse Event
Summary report: N
STOMA STENT
MDR report key: 2351538
·
Received November 21, 2011
Report
- Report Number
- 1220850-2011-00001
- Date Received
- November 21, 2011
- Date of Event
- October 1, 2011
- Report Date
- November 18, 2011
- Manufacturer
- E. BENSON HOOD LAB, INC.
- Product Code
- BTO
- PMA / PMN Number
- K882430
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A PT WAS IN THE PROCESS OF REMOVING A STOMA STENT FROM HIS TRACHEAL STOMA. AS HE PULLED IT OUT, THE STOMA STENT SPLIT INTO TWO PIECES. THE PROXIMAL END WAS IN THE PT'S HAND. THE DISTAL END REMAINED IN THE PT'S STOMA. THE PT WENT TO A LOCAL MEDICAL FACILITY, WHERE A STAFF MEMBER REMOVED THE DISTAL END FROM THE STOMA WITH A PAIR OF FORCEPS AND THE PT WAS RELEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STOMA STENT | STOMA STENT | BTO | E. BENSON HOOD LAB, INC. | CS-11332 | 35061 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |