MAUDE manufacturer profile

SALTER LABS · BYX

MAUDE profile for Tubing, Pressure And Accessories

Key facts

Manufacturer SALTER LABS
Manufacturer group SALTER LABS DE MEXICO DE S.A. DE C.V.
Product code BYX
Product code name Tubing, Pressure And Accessories

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Gas/Air Leak, Adverse Event Without Identified Device or Use Problem, Insufficient Information, Material Twisted/Bent, Disconnection, Connection Problem, Low Oxygen Saturation 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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