MAUDE manufacturer profile

AMERICAN CONTRACT SYSTEMS, INC. · FDE

MAUDE profile for Laparoscopy Kit

Key facts

Manufacturer AMERICAN CONTRACT SYSTEMS, INC.
Manufacturer group AMERICAN CONTRACT SYSTEMS, INC.
Product code FDE
Product code name Laparoscopy Kit

At a glance

  • 1–9 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Material Puncture/Hole, Product Quality Problem, Contamination, Appropriate Term / Code Not Available Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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