MAUDE brand profile

PREMILENE 80 04 60CM 2XDR8 MCV

MAUDE brand safety profile

Key facts

Brand name PREMILENE 80 04 60CM 2XDR8 MCV

At a glance

  • 1–9 MAUDE reports
  • 1–9 Death reports
  • 1–9 Malfunction reports
  • 1–9 Problems coded
  • 1–9 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Detachment of Device or Device Component, Failure To Adhere Or Bond, Break, Death, No Clinical Signs, Symptoms or Conditions 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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