MAUDE manufacturer profile
REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS · FRN
MAUDE profile for Pump, Infusion
Key facts
| Manufacturer | REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS |
|---|---|
| Manufacturer group | REPRO-MED SYSTEMS, INC. DBA KORU MEDICAL SYSTEMS |
| Product code | FRN |
| Product code name | Pump, Infusion |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Insufficient Information, Break, No Known Impact Or Consequence To Patient, Defective Device, Detachment of Device or Device Component, Fluid/Blood Leak, Leak/Splash 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