MAUDE manufacturer profile

COLOPLAST A/S · EZN

MAUDE profile for Dilator, Catheter, Ureteral

Key facts

Manufacturer COLOPLAST A/S
Manufacturer group COLOPLAST A/S MANUFACTURING
Product code EZN
Product code name Dilator, Catheter, Ureteral

At a glance

  • 1–9 MAUDE reports
  • 1–9 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Expiration Date Error, Delivered as Unsterile Product, Device Contamination with Chemical or Other Material, No Apparent Adverse Event, Nonstandard Device, Packaging 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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