FDA Adverse Event
Other
Summary report: N
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
MDR report key: 1151530
·
Received September 5, 2008
Report
- Report Number
- 6000002-2008-08607
- Event Type
- Other
- Date Received
- September 5, 2008
- Date of Event
- July 21, 2008
- Report Date
- August 6, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K926138
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS DISCARDED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL TO SUGGEST THAT A DEATH OR SERIOUS INJURY HAS OCCURRED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4450 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Required Intervention |