MAUDE manufacturer profile

BARD BRACHYTHERAPY, INC. -1424526 · IWJ

MAUDE profile for System, Applicator, Radionuclide, Manual

Key facts

Manufacturer BARD BRACHYTHERAPY, INC. -1424526
Manufacturer group BARD REYNOSA S.A. DE C.V. -9617592
Product code IWJ
Product code name System, Applicator, Radionuclide, Manual

At a glance

  • 10–99 MAUDE reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Unsealed Device Packaging, Tear, Rip or Hole in Device Packaging, No Known Impact Or Consequence To Patient, Device Contamination with Chemical or Other Material, Physical Resistance/Sticking, Material Twisted/Bent, Break 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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