FDA Adverse Event
Injury
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 1040871
·
Received April 28, 2008
Report
- Report Number
- 3003742446-2008-00070
- Event Type
- Injury
- Date Received
- April 28, 2008
- Date of Event
- January 15, 2008
- Report Date
- April 2, 2008
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- RISK MANAGER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS LLC (PR) | NA | 50106309 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| L| R |