FDA Adverse Event
Death
Summary report: N
PRECISE SDS SELF EXPANDING
MDR report key: 1305586
·
Received February 3, 2009
Report
- Report Number
- 9616099-2009-00102
- Event Type
- Death
- Date Received
- February 3, 2009
- Date of Event
- January 7, 2009
- Report Date
- January 7, 2009
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- FGE
- PMA / PMN Number
- K012993
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
Description of Event or Problem · 1
THE REPORT RECEIVED FROM THE STUDY INDICATED THAT A MALE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISE SDS SELF EXPANDING | SELF EXPANDING STENTS (FGE) | FGE | CORDIS DE MEXICO | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Death |