FDA Adverse Event
Malfunction
Summary report: N
PLEURX PLEURAL CATHETER
MDR report key: 314223
·
Received January 25, 2001
Report
- Report Number
- 1717671-2001-00002
- Event Type
- Malfunction
- Date Received
- January 25, 2001
- Date of Event
- August 5, 2000
- Manufacturer
- DENVER BIOMEDICAL, INC.
- Product Code
- KDQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
VALVE ASSEMBLY ON PLEURX PLEURAL CATHETER SEPARATED INTO TWO PIECES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3100 | PLEURX PLEURAL CATHETER | PLEURAL DRAINAGE CATHETER | KDQ | DENVER BIOMEDICAL, INC. | * | 992561 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |