D
Patient 1
THE PRINTER STARTED TO EMIT SMOKE, CAUSING THE PT TO COUGH. THE DOCTOR EXAMINED THE PT NOTED ONLY RENESS OF THE EYES. NO FURTHER MEDICAL TREATMENT WAS REQUIRED.
MAUDE MDR 506120
- MDR report key
- 506120
- Report number
- 2918630-2003-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2003-11-19
- Date received
- 2003-12-19
- 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#
- Address
- 5160 HACIENDA DR 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 | HUMPHREY AUTOMATIC REFRACTOR KERATOMETER | OBJECTIVE REFRACTOR | CARL ZEISS MEDITEC INC | HNO | 597 | NA | NA | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2003-12-19 | 0 |