FDA Adverse Event
Other
Summary report: N
CARPENTIER EDWARDS PHYSIO MITRAL ANNULOPLASTY RING
MDR report key: 1014107
·
Received March 12, 2008
Report
- Report Number
- 6000002-2008-06200
- Event Type
- Other
- Date Received
- March 12, 2008
- Date of Event
- February 1, 2008
- Report Date
- February 19, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED IN 2008. THE REASON FOR THE EXPLANT IS UNK. REPORTEDLY, THE DEVICE WAS IMPLANTED IN THE SAME DAY OF EXPLANT. NO OTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER EDWARDS PHYSIO MITRAL ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 445028MM | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |