FDA Adverse Event
Death
Summary report: N
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT
MDR report key: 1081703
·
Received July 22, 2008
Report
- Report Number
- 6000002-2008-08142
- Event Type
- Death
- Date Received
- July 22, 2008
- Date of Event
- January 16, 2008
- Report Date
- January 16, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K980487
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO UNKNOWN REASONS. DATE OF DEATH IS UNKNOWN. AWARE DATE IS USED AS INCIDENT DATE. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4625 | R-07J1861 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |