FDA Adverse Event
Other
Summary report: N
URINARY DRAINAGE BAG
MDR report key: 28544
·
Received November 10, 1995
Report
- Report Number
- 1483039-1995-00020
- Event Type
- Other
- Date Received
- November 10, 1995
- Date of Event
- October 22, 1995
- Report Date
- November 9, 1995
- Manufacturer
- PLASCO, INC.
- Product Code
- FCN
- Report Source
- Distributor report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
HEALTH CARE PROFESSIONAL REPORTED THAT PT DEVELOPED A URINARY TRACT INFECTION AS A RESULT OF URINE BACKING-UP INTO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | URINARY DRAINAGE BAG | URINARY DRAINAGE BAG | FCN | PLASCO, INC. | 6633-345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |