FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING
MDR report key: 1030110
·
Received April 14, 2008
Report
- Report Number
- 6000002-2008-06523
- Event Type
- Injury
- Date Received
- April 14, 2008
- Date of Event
- February 25, 2008
- Report Date
- March 14, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 ZERO DAYS; HOWEVER, THE REASON FOR EXPLANT IS UNK. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4400M26 | R-07H1549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |