MAUDE manufacturer profile

BIOSENSE WEBSTER, INC (IRWINDALE) · LPB

MAUDE profile for Cardiac Ablation Percutaneous Catheter

Key facts

Manufacturer BIOSENSE WEBSTER, INC (IRWINDALE)
Manufacturer group BIOSENSE WEBSTER, INC (IRWINDALE)
Product code LPB
Product code name Cardiac Ablation Percutaneous Catheter

At a glance

  • 100–999 MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 100–999 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Insufficient Information, Cardiac Tamponade, Pericardial Effusion, Death, Hematoma, Device Contamination with Chemical or Other Material, Transient Ischemic Attack 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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