FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING
MDR report key: 1081846
·
Received July 22, 2008
Report
- Report Number
- 6000002-2008-08150
- Event Type
- Injury
- Date Received
- July 22, 2008
- Date of Event
- November 13, 2007
- Report Date
- December 7, 2007
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K926138
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED IN 2007, AFTER AN IMPLANT DURATION OF ZERO DAYS, DUE TO UNK REASONS. 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 PHYSIO MITRAL ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4450 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |