FDA Adverse Event
Other
Summary report: N
WALLFLEX ESOPHAGEAL STENT
MDR report key: 1750051
·
Received July 1, 2010
Report
- Report Number
- MW5016597
- Event Type
- Other
- Date Received
- July 1, 2010
- Date of Event
- May 29, 2010
- Report Date
- July 1, 2010
- Manufacturer
- BOSTON SCIENTIFIC CORP HEADQUARTERS
- Product Code
- ESW
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
OPERATING ROOM: ESOPHAGEAL STENT USED FOR PROCEDURE, EXPIRED 05/20/2010. DR USED STENT BECAUSE IT IS THE ONLY ONE AVAILABLE. STENT OBTAINED FROM GI LAB. DIAGNOSIS OR REASON FOR USE: SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WALLFLEX ESOPHAGEAL STENT | WALLFLEX ESOPHAGEAL STENT | ESW | BOSTON SCIENTIFIC CORP HEADQUARTERS | 1675 | 13053161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |