D
Patient 1
THE CUSTOMER REPORTED THAT TWO CATHETERS WOULD NOT CONNECT TO THE INFLATOR. THE PT WAS ALREADY ANESTHETIZED. THE THIRD CATHETER WORKED.
MAUDE MDR 454910
- MDR report key
- 454910
- Report number
- 1649914-2003-00021
- Event key
- 0
- Event type
- 3
- Date of event
- 2003-03-06
- Date received
- 2003-04-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- KATHRYN THOMPSON
- Address
- ONE ALLENTOWN PKWY ALLEN TX 75002 US
- Phone
- 972-972-9723
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LACRICATH 2.0MM | LACRIMAL DUCT BALLOON CATHETER | QUEST MEDICAL, INC. | HNW | LDC213 | * | AM052802-1 | N | * | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2003-04-16 | 0 |