MAUDE brand profile

FLEXOR INTRODUCER SHEATH

MAUDE brand safety profile

Key facts

Brand name FLEXOR INTRODUCER SHEATH

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • Material Separation, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Detachment of Device or Device Component, No Consequences Or Impact To Patient, Nonstandard Device, Unraveled Material, Break 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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