FDA Adverse Event
Injury
Summary report: N
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
MDR report key: 1101004
·
Received August 6, 2008
Report
- Report Number
- 6000002-2008-08352
- Event Type
- Injury
- Date Received
- August 6, 2008
- Date of Event
- July 14, 2008
- Report Date
- July 14, 2008
- Manufacturer
- EDWARDS LIFESCEINCES
- Product Code
- KRH
- PMA / PMN Number
- K923367
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, 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 DUE TO UNKNOWN REASONS. THE IMPLANT DURATION IS UNKNOWN, THEREFORE THE AWARE DATE IS BEING USED AS THE OCCURRENCE DATE. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COSGROVE-EDWARDS ANNULOPLASTY SYSTEM | ANNULOPLASTY RING | KRH | EDWARDS LIFESCEINCES | 4600 | 5M2232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |