FDA Adverse Event
Injury
Summary report: N
GIA 80-3.8 SINGLE USE RELOADABLE STAPLER
MDR report key: 1374658
·
Received May 4, 2009
Report
- Report Number
- 2647580-2009-00213
- Event Type
- Injury
- Date Received
- May 4, 2009
- Date of Event
- February 26, 2009
- Report Date
- April 6, 2009
- Manufacturer
- PONCE - USS
- Product Code
- GDW
- PMA / PMN Number
- K013860
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF INITIAL REPORT: 05/04/2009.
Description of Event or Problem · 1
PROCEDURE: COLOSTOMY. ACCORDING TO THE REPORTER: POST OPERATIVE STAPLE LINE LEAK AND INFECTION WERE NOTED. COVIDIEN HAS REQUESTED FURTHER PATIENT AND INCIDENT DETAILS FROM THE REPORTER. TO DATE, NO FURTHER INFORMATION HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIA 80-3.8 SINGLE USE RELOADABLE STAPLER | NONE | GDW | PONCE - USS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |