MAUDE brand profile

PFC SIGMA FEM POST AUG SZ4 8MM

MAUDE brand safety profile

Key facts

Brand name PFC SIGMA FEM POST AUG SZ4 8MM

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Pain, Loss of or Failure to Bond, No Code Available, Joint Laxity, Appropriate Term / Code Not Available, Malposition of Device, Insufficient Information 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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