MAUDE manufacturer profile

BELLCO SRL · QIR

MAUDE profile for Pediatric Hemodialysis System

Key facts

Manufacturer BELLCO SRL
Manufacturer group BELLCO SRL
Product code QIR
Product code name Pediatric Hemodialysis System

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Smoking, Display or Visual Feedback Problem, Insufficient Information, Protective Measures Problem, Hemorrhage/Blood Loss/Bleeding, Adverse Event Without Identified Device or Use Problem, Product Quality Problem 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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