FDA Adverse Event
Injury
Summary report: N
CORDIS GENESIS
MDR report key: 2081849
·
Received May 4, 2011
Report
- Report Number
- MW5020511
- Event Type
- Injury
- Date Received
- May 4, 2011
- Date of Event
- April 7, 2011
- Report Date
- April 19, 2011
- Product Code
- FGE
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
ENDOVASCULAR STENT TO LEFT MAINSTEM BRONCHUS (OFF LABEL USE). CANCER/AIRWAY OCCLUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORDIS GENESIS | TRANSEPTIC BILIARY STENT | FGE | 15244589 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |