MAUDE brand profile

2CM PERIPHERAL CUTTING BALLOON

MAUDE brand safety profile

Key facts

Brand name 2CM PERIPHERAL CUTTING BALLOON

At a glance

  • 1,000+ MAUDE reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • Material Rupture, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Leak/Splash, Detachment of Device or Device Component, Difficult to Remove, Inflation Problem, Device Dislodged or Dislocated Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE brand safety profiles

Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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