D
Patient 1
PT'S SPOUSE TOLD THE NURSING STAFF THAT WHEN PT USED THE URINAL, IT CUT THEM. BLOODY DRAINAGE NOTED AT BASE OF PENIS AND FORESKIN AREAS. COLD PACKS APPLIED IMMEDIATELY.
MAUDE MDR 497235
- MDR report key
- 497235
- Report number
- 497235
- Event key
- 0
- Event type
- 3
- Date of event
- 2003-11-12
- Date received
- 2003-11-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VOLLRATH | MALE URINAL | MEDEGEN MEDICAL PRODUCTS | FNP | H140D-01 | UNK | UNK | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2003-11-20 | 0 | 1. O |