MAUDE manufacturer profile

TERUMO CORPORATION - KOFU · FPA

MAUDE profile for Set, Administration, Intravascular

Key facts

Manufacturer TERUMO CORPORATION - KOFU
Manufacturer group TERUMO CORPORATION, KOFU
Product code FPA
Product code name Set, Administration, Intravascular

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Needle Stick/Puncture, Break, Patient-Device Incompatibility, Skin Inflammation, Edema, No Known Impact Or Consequence To Patient, Device Embedded In Tissue or Plaque, Improper or Incorrect Procedure or Method 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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