FDA Adverse Event
Other
Summary report: N
CARPENTIER EDWARDS PHYSIO MITRAL ANNULOPLASTY RING
MDR report key: 1014102
·
Received March 12, 2008
Report
- Report Number
- 6000002-2008-06201
- 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
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 THE SAME DAY. NO FURTHER 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 | 5B0260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |