FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
MDR report key: 1231826
·
Received November 11, 2008
Report
- Report Number
- 6000002-2008-09244
- Event Type
- Injury
- Date Received
- November 11, 2008
- Date of Event
- October 23, 2008
- Report Date
- October 23, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UNSUCCESSFUL RING REPAIR. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AT IMPLANT DUE TO FAILED RING REPAIR. REPORTEDLY, THE DEVICE DID NOT WORK. IT WAS REPORTED THAT THE DEVICE IS BEING RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4450 | R-06G134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |