FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
MDR report key: 1202988
·
Received October 16, 2008
Report
- Report Number
- 6000002-2008-08961
- Event Type
- Injury
- Date Received
- October 16, 2008
- Date of Event
- September 17, 2008
- Report Date
- October 10, 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
REPORTEDLY THE DEVICE WAS EXPLANTED AND REPLACED BY A 6900P VALVE AFTER AN IMPLANT DURATION OF NINE (9) MONTHS, DUE TO UNK REASONS. 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 RING | KRH | EDWARDS LIFESCIENCES | 4450 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |