FDA Adverse Event
Injury
Summary report: N
EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
MDR report key: 1100803
·
Received August 6, 2008
Report
- Report Number
- 6000002-2008-08348
- Event Type
- Injury
- Date Received
- August 6, 2008
- Date of Event
- July 9, 2008
- Report Date
- July 9, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K020864
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED. THE IMPLANT DURATION IS UNKNOWN, THEREFORE, THE AWARE DATE IS BEING USED AS THE OCCURRENCE DATE. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4900 | R-07H1668 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |