D
Patient 1
THE CUSTOMER REPORTED A HAZE COMING FROM THEIR UNIT. THE CUSTOMER STATED THAT THERE WERE NO REPORTS OF PHYSICIAL SYMPTOMS RELATED TO THE OIL MIST. THE ASP FIELD SVC ENGINEER WENT TO THE FACILITY TO REPAIR THE UNIT.
MAUDE MDR 918242
- MDR report key
- 918242
- Report number
- 2084725-2007-00270
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-08-28
- Date received
- 2007-09-25
- 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
- STEVE PRIOLO
- Address
- 33 TECHNOLOGY DR. IRVINE CA 92618 US
- Phone
- 949-949-9497
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STERRAD 200 STERILIZATION SYSTEM | STERILIZER | YAMATO LAB-TECH CO., LTD | FLF | 10201-001 | NA | NA | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-09-25 | 0 |
Event Narratives#
N
Patient 1
.