FDA Adverse Event
Other
Summary report: N
GEOFORM ANNULOPLASTY RING MITRAL
MDR report key: 1022555
·
Received March 27, 2008
Report
- Report Number
- 6000002-2008-06372
- Event Type
- Other
- Date Received
- March 27, 2008
- Date of Event
- January 7, 2008
- Report Date
- March 3, 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
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED IN 2008 AFTER AN IMPLANT DURATION OF 6 MONTHS DUE TO AN UNK REASON. IT IS UNK IF THE EXPLANT WAS ATTRIBUTED TO THE DEVICE, AS NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEOFORM ANNULOPLASTY RING MITRAL | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4200 | 6J0352 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |