D
Patient 1
A PATIENT EXPERIENCED AN ELECTROSTATIC DISCHARGE WHEN TOUCHING THE DEVICE PT MODULE. THE DISCHARGE OCCURRED IN THE VICINITY OF THE PT'S EYE.
MAUDE MDR 615698
- MDR report key
- 615698
- Report number
- 2918630-2005-00004
- Event key
- 0
- Event type
- 3
- Date of event
- 2005-04-05
- Date received
- 2005-06-03
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 112
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Address
- 5160 HACIENDA DRIVE DUBLIN CA 94568 US
- Phone
- 925-925-9255
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STRATUSOCT | OPTICAL CORNEAL TOMOGRAPHY | CARL ZEISS MEDITEC INC | HLI | 3000 | NA | NA | K030433 | N | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2005-06-03 | 0 | 1. O |