MAUDE manufacturer profile

KORU MEDICAL SYSTEMS · FRN

MAUDE profile for Pump, Infusion

Key facts

Manufacturer KORU MEDICAL SYSTEMS
Manufacturer group KORU MEDICAL SYSTEMS
Product code FRN
Product code name Pump, Infusion

At a glance

  • 100–999 MAUDE reports
  • 1–9 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Unintended Ejection, Insufficient Information, Break, Noise, Audible, Mechanical Problem, Defective Device, Infusion or Flow Problem 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

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