FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
MDR report key: 1202883
·
Received October 16, 2008
Report
- Report Number
- 6000002-2008-08948
- Event Type
- Death
- Date Received
- October 16, 2008
- Date of Event
- September 3, 2008
- Report Date
- September 29, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K926138
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
EXPLANT AT IMPLANT. PATIENT EXPIRED SAME DATE. REASON UNKNOWN. NO FURTHER DETAILS WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED (DISCARDED).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING | ANNULOPLASTY | KRH | EDWARDS LIFESCIENCES | 4450 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| H| R |