MAUDE manufacturer profile

MERZ NORTH AMERICA, INC. · OHV

MAUDE profile for Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Key facts

Manufacturer MERZ NORTH AMERICA, INC.
Manufacturer group MERZ-WISCONSIN
Product code OHV
Product code name Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Pain, Scar Tissue, Burn(s), Expiration Date Error, Inaccurate Information, Output Problem 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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