FDA Adverse Event
Malfunction
Summary report: N
FOGARTY EMBOLECTOMY CATHETER
MDR report key: 1082682
·
Received July 21, 2008
Report
- Report Number
- 6000002-2008-08089
- Event Type
- Malfunction
- Date Received
- July 21, 2008
- Date of Event
- May 26, 2008
- Report Date
- May 30, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DXE
- PMA / PMN Number
- PREAMEND
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT BEFORE USE, THE FRONT OF TIP IS CROOKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOGARTY EMBOLECTOMY CATHETER | EMBOLECTOMY CATHETER | DXE | EDWARDS LIFESCIENCES | 120404F | 58447135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |