MAUDE manufacturer profile

ST PAUL · FRN

MAUDE profile for Pump, Infusion

Key facts

Manufacturer ST PAUL
Product code FRN
Product code name Pump, Infusion

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 100–999 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Device Alarm System, Insufficient Information, Mechanical Problem, Audible Prompt/Feedback Problem, No Patient Involvement, No Information, Device Sensing 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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