FDA Adverse Event
Other
Summary report: N
LIFEPORT VASCULAR ACCESS SYSTEM
MDR report key: 208632
·
Received February 4, 1999
Report
- Report Number
- 1056436-1999-00003
- Event Type
- Other
- Date Received
- February 4, 1999
- Date of Event
- January 6, 1999
- Report Date
- January 6, 1999
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ON 01/06/1999, THE MANUFACTURER'S CUSTOMER SERVICE REPRESENTATIVE OF THE FOLLOWING: THE CUSTOMER STATED THAT THEY REC'D THE PRODUCT WITH SPANISH PT MANUALS. THE MANUALS SHOULD BE ENGLISH. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPORT VASCULAR ACCESS SYSTEM | VASCULAR ACCESS DEVICE | LJT | HORIZON MEDICAL PRODUCTS, INC. | NA | 14578 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |