FDA Adverse Event
Other
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
MDR report key: 1151528
·
Received September 5, 2008
Report
- Report Number
- 6000002-2008-08608
- Event Type
- Other
- Date Received
- September 5, 2008
- Date of Event
- July 14, 2008
- Report Date
- August 6, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS WASTED. 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 PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 2700TFX | R-08B0199 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Required Intervention |