D
Patient 1
INFORMATION WAS RECEIVED INDICATING THAT THERE WAS A SWITCH ISSUE TO A SMITHS MEDICAL LEVEL 1? HOTLINE? LOW FLOW SYSTEM. THERE WERE NO REPORTED ADVERSE EFFECTS.
MAUDE MDR 9887345
- MDR report key
- 9887345
- Report number
- 3012307300-2020-02161
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- DAVE HALVERSON
- Address
- 6000 NATHAN LANE N MINNEAPOLIS,, MN US
- Phone
- 383-383-3833
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LEVEL 1? HOTLINE? LOW FLOW SYSTEM | WARMER, THERMAL, INFUSION FLUID | SMITHS MEDICAL ASD; INC. | LGZ | HL-90 | CON-HL-90 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-27 | 0 |