MAUDE brand profile

ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 29MM 30BX

MAUDE brand safety profile

Key facts

Brand name ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 29MM 30BX

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • Nonstandard Device, No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Difficult to Remove, No Information, Pain, Sticking, Device Operates Differently Than Expected 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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