MAUDE manufacturer profile

COLOPLAST A/S · FQH

MAUDE profile for Lavage, Jet

Key facts

Manufacturer COLOPLAST A/S
Manufacturer group CMF-SARLAT
Product code FQH
Product code name Lavage, Jet

At a glance

  • 100–999 MAUDE reports
  • 1–9 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Suction Failure, Inability to Irrigate, Suction Problem, Device Misassembled During Manufacturing /Shipping, Unsealed Device Packaging, Free or Unrestricted Flow, Device Contaminated During Manufacture or Shipping 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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