MAUDE brand profile

FLEXISEAL SIGNAL FECAL MANAGEMENT SYSTEM

MAUDE brand safety profile

Key facts

Brand name FLEXISEAL SIGNAL FECAL MANAGEMENT SYSTEM

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Fluid/Blood Leak, Use of Device Problem, Pressure Sores, Overfill, Material Separation, Blood Loss 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

Browse all MAUDE brand safety profiles