MAUDE manufacturer profile

REFLEXION MEDICAL, INC. · QVA

MAUDE profile for Fludeoxyglucose F18-Guided Radiation Therapy System

Key facts

Manufacturer REFLEXION MEDICAL, INC.
Manufacturer group REFLEXION MEDICAL, INC.
Product code QVA
Product code name Fludeoxyglucose F18-Guided Radiation Therapy System

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Appropriate Term / Code Not Available, Use of Device Problem, Urinary Frequency, Use of Incorrect Control/Treatment Settings, Unspecified Kidney or Urinary Problem, Burning Sensation, Insufficient Information 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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