FDA Adverse Event
Injury
Summary report: N
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
MDR report key: 1031571
·
Received April 18, 2008
Report
- Report Number
- 6000002-2008-06592
- Event Type
- Injury
- Date Received
- April 18, 2008
- Date of Event
- February 19, 2008
- Report Date
- March 21, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, 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 AFTER AN IMPLANT DURATION OF 0.17 MONTH. THE REASON FOR EXPLANT IS UNK. NO FURTHER DETAILS WERE PROVIDED. INFORMATION 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 | R-07H1694 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |