FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
MDR report key: 1181644
·
Received September 29, 2008
Report
- Report Number
- 6000002-2008-08802
- Event Type
- Injury
- Date Received
- September 29, 2008
- Date of Event
- September 11, 2008
- Report Date
- September 22, 2008
- Manufacturer
- EDWARDS LIFESIENCES
- Product Code
- KRH
- PMA / PMN Number
- K926138
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, DEVICE WAS EXPLANTED AFTER IMPLANT DURATION OF 29 MONTHS. IMPLANT DATE 2006: EXPLANT DATE 2008. DEVICE IS UNAVAILABLE FOR RETURN. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESIENCES | 4450 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |