MAUDE manufacturer profile

INRAD · KNW

MAUDE profile for Instrument, Biopsy

Key facts

Manufacturer INRAD
Manufacturer group RLS INTERVENTIONAL INC. DBA INRAD
Product code KNW
Product code name Instrument, Biopsy

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Foreign Body In Patient, Material Fragmentation, Product Quality Problem, Adverse Event Without Identified Device or Use Problem, Insufficient Information, Particulates, Break, Device Embedded In Tissue or Plaque 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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