MAUDE manufacturer profile

VYGON USA · FOZ

MAUDE profile for Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Key facts

Manufacturer VYGON USA
Manufacturer group VYGON MFG
Product code FOZ
Product code name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Fluid/Blood Leak, No Information, No Known Impact Or Consequence To Patient, Material Fragmentation, Fracture, Break, Device Embedded In Tissue or Plaque, No Clinical Signs, Symptoms or Conditions 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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