FDA Adverse Event
Injury
Summary report: N
LIFE PORT
MDR report key: 10758
·
Received January 4, 1994
Report
- Report Number
- 10758
- Event Type
- Injury
- Date Received
- January 4, 1994
- Report Date
- October 26, 1993
- Manufacturer
- STRATO MEDICAL CORP.
- Product Code
- DQO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
CATHETER LEAKING AT MIDPOINT. CATHETER HAD TO BE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFE PORT Implant | DQO | STRATO MEDICAL CORP. | 231801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |