N
Patient 1
THE INSTRUMENT HAS BEEN INVESTIGATED. THE PHOTOMETER FILTER BLOCK LENS, AND VACUUM PUMP WERE CLEANED. THE MANIFOLD O-RINGS WERE REPLACED. THE INSTRUMENT WAS INSPECTED, TESTED WITHOUT FURTHER PROBLEM, AND RETURNED TO SERVICE.
MAUDE MDR 741608
- MDR report key
- 741608
- Report number
- 2250051-2005-00450
- Event key
- 0
- Event type
- 3
- Date received
- 2005-09-30
- Adverse event
- 0
- Product problem
- 0
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- LAURA VELLUCCI PH.D.
- Address
- 1001 US HWY 202 RARITAN NJ 08869 US
- Phone
- 908-908-9082
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JTL | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2005-09-30 | 0 |