MAUDE manufacturer profile

MEDTRONIC IRELAND · PRC

MAUDE profile for Drug-Coated Peripheral Transluminal Angioplasty Catheter

Key facts

Manufacturer MEDTRONIC IRELAND
Manufacturer group MEDTRONIC IRELAND
Product code PRC
Product code name Drug-Coated Peripheral Transluminal Angioplasty Catheter

At a glance

  • 100–999 MAUDE reports
  • 100–999 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Stenosis, Thrombosis/Thrombus, No Clinical Signs, Symptoms or Conditions, Hemorrhage/Blood Loss/Bleeding, Obstruction/Occlusion, Renal Failure, 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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