MAUDE brand profile

EDWARDS PERICARDIAL PATCH

MAUDE brand safety profile

Key facts

Brand name EDWARDS PERICARDIAL PATCH

At a glance

  • 100–999 MAUDE reports
  • 100–999 Death reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Fluid/Blood Leak, No Information, Appropriate Term/Code Not Available, Unsealed Device Packaging, No Patient Involvement, Delivered as Unsterile Product 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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