FDA Adverse Event
Other
Summary report: N
INFUSION CATHETER, 7F
MDR report key: 460808
·
Received April 28, 2003
Report
- Report Number
- 6000002-2003-00175
- Event Type
- Other
- Date Received
- April 28, 2003
- Date of Event
- May 22, 2002
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DQO
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
THE MEDWATCH REPORT WAS RECEIVED AT EDWARDS LIFESCIENCES MARCH 2003. FOLLOW-UP HOSPITAL REPORTER, INDICATED THAT THEY WOULD REVIEW THE PT'S MEDICAL RECORD TO LEARN MORE DETAILS ABOUT THE REPORT. FOLLOW-UP CALLS WERE MADE BY REGULATORY OF EDWARDS LIFESCIENCES IN 3/2003. A CALL BACK IN 2003, INDICATED THAT THE PT WAS TAKEN TO THE CARDIAC CATHETERIZATION LABORATORY IN 2002 FOR RETRIEVAL OF DISTAL PORTION OF THE DEVICE. IT WAS STATED THAT THERE WERE NO PT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFUSION CATHETER, 7F | CENTRAL VENOUS CATHETER | DQO | EDWARDS LIFESCIENCES | MIC17F7H | 950EC051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |