MAUDE brand profile

PENTA

MAUDE brand safety profile

Key facts

Brand name PENTA

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 1,000+ Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • Inadequate Pain Relief, Adverse Event Without Identified Device or Use Problem, Device Operates Differently Than Expected, Impedance Problem, Discomfort, Device Overstimulation of Tissue, High impedance, Pain 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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