MAUDE brand profile

RESTORE ULTRA MRI

MAUDE brand safety profile

Key facts

Brand name RESTORE ULTRA MRI

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • Pain, Therapeutic Effects, Unexpected, Device Operates Differently Than Expected, Burning Sensation, Therapy Delivered to Incorrect Body Area, Undesired Nerve Stimulation, Unexpected Therapeutic Results, Device Displays Incorrect Message 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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