FDA Adverse Event
Injury
Summary report: N
LIFEPORT VASCULAR ACCESS SYSTEM
MDR report key: 314741
·
Received February 2, 2001
Report
- Report Number
- 1056436-2001-00004
- Event Type
- Injury
- Date Received
- February 2, 2001
- Date of Event
- December 11, 2000
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LJT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 01/16/2001, THE MFR RECEIVED MEDWATCH REPORT (UF# 44-0049-2000-0009) FROM THE FACILITY THAT STATES THE FOLLOWING: A FRAGMENT THAT HAD BROKEN OFF OF A DEVICE WAS IDENTIFIED WITHIN THE HEART OF THE PT. THE CATHETER HAD BEEN IMPLANTED 08/2000. IT HAD TO BE REMOVED SURGICALLY. NO FURTHER DETAILS ARE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3947 | LIFEPORT VASCULAR ACCESS SYSTEM | VASCULAR ACCESS DEVICE | LJT | HORIZON MEDICAL PRODUCTS, INC. | NA | 15075 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |