MAUDE brand profile

CROME DR MRI SURESCAN

MAUDE brand safety profile

Key facts

Brand name CROME DR MRI SURESCAN

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Unspecified Infection, Device Sensing Problem, Mechanical Problem, Inappropriate/Inadequate Shock/Stimulation, Shock from Patient Lead(s), Pacing Problem 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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