MAUDE manufacturer profile

PROFOUND MEDICAL INC · PLP

MAUDE profile for High Intensity Ultrasound System For Prostate Tissue Ablation

Key facts

Manufacturer PROFOUND MEDICAL INC
Manufacturer group PROFOUND MEDICAL INC
Product code PLP
Product code name High Intensity Ultrasound System For Prostate Tissue Ablation

At a glance

  • 1–9 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Difficult to Insert, Adverse Event Without Identified Device or Use Problem, Perforation, Appropriate Term / Code Not Available 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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