FDA Adverse Event
Malfunction
Summary report: N
SMART CONTROL NITINOL STENT SYSTEM
MDR report key: 1023796
·
Received April 1, 2008
Report
- Report Number
- 9616099-2008-00838
- Event Type
- Malfunction
- Date Received
- April 1, 2008
- Date of Event
- March 6, 2008
- Report Date
- March 6, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- FGE
- PMA / PMN Number
- K021898
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
UPON OPENING THE PRODUCT PACKAGE PRIOR TO USE, IT WAS NOTED THAT ONE END OF THE INNER STERILE POUCH WAS NOT COMPLETELY SEALED. THE PRODUCT WAS NOT USED CLINICALLY. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMART CONTROL NITINOL STENT SYSTEM | SELF EXPANDING STENTS (FGE) | FGE | CORDIS DE MEXICO | NA | 13308170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |