FDA Adverse Event
Injury
Summary report: N
TRIUMPH-1 PORT
MDR report key: 418979
·
Received September 30, 2002
Report
- Report Number
- 1056436-2002-00123
- Event Type
- Injury
- Date Received
- September 30, 2002
- Date of Event
- August 30, 2002
- Report Date
- September 30, 2002
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- LJT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
ON 09/03/2002, THE PATIENT'S SPOUSE INFORMED THE MANUFACTURER'S REPRESENTATIVE OF THE FOLLOWING: PATIENT WENT FOR ROUTINE CHEMO TREATMENT. PATIENT EXPERIENCED EXCRUCIATING PAIN. X-RAY PERFORMED, DEVICE CATHETER MIGRATED TO ARTERY. DEVICE EXPLANTED. PATIENT DOES NOT KNOW NAME OF THE USER FACILITY RIGHT OFF HAND, DOES NOT KNOW IF USER FACILITY SAVED DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIUMPH-1 PORT | VASCULAR ACCESS PORT | LJT | HORIZON MEDICAL PRODUCTS, INC. | NA | 3-515051B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention |