MAUDE brand profile

PLEXA PROMRI S 60

MAUDE brand safety profile

Key facts

Brand name PLEXA PROMRI S 60

At a glance

  • 100–999 MAUDE reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Unspecified Infection, Device Dislodged or Dislocated, Ambient Noise Problem, Failure to Capture, High Capture Threshold, Over-Sensing 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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