MAUDE brand profile

PRIMEADVANCED

MAUDE brand safety profile

Key facts

Brand name PRIMEADVANCED

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 1,000+ Injury reports
  • 1,000+ Malfunction reports
  • 100–999 Problems coded
  • 100–999 Problems flagged by Orca1 signal analytics
  • Therapeutic Effects, Unexpected, Device Operates Differently Than Expected, Pain, No Known Impact Or Consequence To Patient, Adverse Event Without Identified Device or Use Problem, Failure to Deliver Energy, High impedance, Therapeutic Response, Decreased 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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