FDA Adverse Event
Injury
Summary report: N
EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
MDR report key: 1081836
·
Received July 22, 2008
Report
- Report Number
- 6000002-2008-08161
- Event Type
- Injury
- Date Received
- July 22, 2008
- Date of Event
- July 11, 2008
- Report Date
- July 11, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K020864
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL #4450 WAS EXPLANTED. REFER TO MFR #6000002-2008-08160. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM IMPLANT PATIENT 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-08D0794 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |