FDA Adverse Event
Other
Summary report: N
EDWARDS GEOFORM MITRAL ANNULOPLASTY RING
MDR report key: 1014108
·
Received March 12, 2008
Report
- Report Number
- 6000002-2008-06199
- Event Type
- Other
- Date Received
- March 12, 2008
- Report Date
- February 19, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. THE REASON AND THE EVENT DATE ARE UNKNOWN. REPORTEDLY, THE DEVICE WAS IMPLANTED IN 2008. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EDWARDS GEOFORM MITRAL ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4200 26MM | 7A0170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |