MAUDE brand profile

ULTIPACE LEAD 52CM MRI

MAUDE brand safety profile

Key facts

Brand name ULTIPACE LEAD 52CM MRI

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem, Failure to Capture, Unspecified Infection, Capturing Problem, Over-Sensing, Failure to Sense 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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