FDA Adverse Event
Injury
Summary report: N
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
MDR report key: 1091887
·
Received July 31, 2008
Report
- Report Number
- 6000002-2008-08278
- Event Type
- Injury
- Date Received
- July 31, 2008
- Date of Event
- July 23, 2008
- Report Date
- July 23, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K923367
- 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 UNK, 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 | COSGROVE-EDWARDS ANNULOPLASTY SYSTEM | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4600 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |