D
Patient 1
PT HAD FOLEY CATHETER PLACED IN EMERGENCY ROOM. DRAINAGE BAG HAD A SLOW LEAK AT DRAIN SPOUT. NEW CYSTOFLO BAG APPLIED. PACKAGE NOT AVAILABLE AS PRODUCT PUT IN ANOTHER DEPARTMENT.
MAUDE MDR 217145
- MDR report key
- 217145
- Report number
- MW1016043
- Event key
- 0
- Event type
- 3
- Date of event
- 1999-03-05
- Date received
- 1999-04-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Report source
- P
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DOVER | URINARY DRAINAGE | SHERWOOD MEDICAL CO. | FCN | * | 601709 | 808407 | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1999-04-01 | 0 |