MAUDE manufacturer profile
FLOWONIX MEDICAL, INC. · LKK
MAUDE profile for Pump, Infusion, Implanted, Programmable
Key facts
| Manufacturer | FLOWONIX MEDICAL, INC. |
|---|---|
| Manufacturer group | FLOWONIX MEDICAL, INC. |
| Product code | LKK |
| Product code name | Pump, Infusion, Implanted, Programmable |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Inadequate Pain Relief, Adverse Event Without Identified Device or Use Problem, Insufficient Flow or Under Infusion, Patient Problem/Medical Problem, No Clinical Signs, Symptoms or Conditions, Unspecified Infection, Pain, Device Operates Differently Than Expected Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1