D
Patient 1
THE USER ALLEGES THAT THEY HAD ONE PATIENT THAT HAD A LATEX REACTION TO THE URETERAL DRAINAGE BAG. THE PATIENT DEVELOPED A RASH.
MAUDE MDR 425109
- MDR report key
- 425109
- Report number
- 1217052-2002-00033
- Event key
- 0
- Event type
- 3
- Date received
- 2002-10-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- BRIAN FARIAS
- Address
- 10 BOWMAN DRIVE KEENE NH 03431 US
- Phone
- 603-603-6033
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | URETERAL DRAINAGE BAG | URETERAL DRAINAGE BAG | PORTEX, INC. | EXG | NA | 7000 | UNK | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2002-10-30 | 0 |