MAUDE manufacturer profile

AV-TEMECULA-CT · MGB

MAUDE profile for Device, Hemostasis, Vascular

Key facts

Manufacturer AV-TEMECULA-CT
Manufacturer group CLONMEL, IRELAND REG# 9616693
Product code MGB
Product code name Device, Hemostasis, Vascular

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 1,000+ Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Consequences Or Impact To Patient, Device Operates Differently Than Expected, Detachment Of Device Component, Positioning Failure, Failure to Cycle, Improper or Incorrect Procedure or Method, Difficult to Remove, Material Separation 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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