MAUDE manufacturer profile

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION · GFA

MAUDE profile for Blade, Saw, General & Plastic Surgery, Surgical

Key facts

Manufacturer TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Manufacturer group SAME
Product code GFA
Product code name Blade, Saw, General & Plastic Surgery, Surgical

At a glance

  • 100–999 MAUDE reports
  • 1–9 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Consequences Or Impact To Patient, No Patient Involvement, Device Operates Differently Than Expected, Device Inoperable, Bent, Mechanical Problem, No Information, No Known Impact Or Consequence To Patient 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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