MAUDE brand profile

HYPERSOFT ADVANCED HYPERSOFT

MAUDE brand safety profile

Key facts

Brand name HYPERSOFT ADVANCED HYPERSOFT

At a glance

  • 1–9 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 1–9 Problems coded
  • 1–9 Problems flagged by Orca1 signal analytics
  • Aneurysm, No Consequences Or Impact To Patient, Premature Activation, Detachment Of Device Component, Detachment of Device or Device Component, Break, No Known Impact Or Consequence To Patient, Difficult To Position 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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