FDA Adverse Event
Other
Summary report: N
BARDEX
MDR report key: 283813
·
Received June 19, 2000
Report
- Report Number
- MW1019191
- Event Type
- Other
- Date Received
- June 19, 2000
- Date of Event
- June 7, 2000
- Report Date
- June 19, 2000
- Manufacturer
- C.R. BARD, INC.
- Product Code
- KOD
- Report Source
- Voluntary report
- Reporter Location
- NH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
CATHETER TO BE REMOVED ON 6/7/00. WHEN DEFLATING BALLOON, ONLY SOME OF FLUID (ABOUT 4CC) ABLE TO BE REMOVED. BALLOON REMAINED PARTIALLY INFLATED WITH APPROXIMATELY 1CC OF FLUID. CATHETER REMOVED FROM PT WITH MILD DISCOMFORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARDEX | FOLEY CATHETER - 16FR | KOD | C.R. BARD, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other |