MAUDE manufacturer profile

COLOPLAST A/S · EZL

MAUDE profile for Catheter, Retention Type, Balloon

Key facts

Manufacturer COLOPLAST A/S
Manufacturer group CMF-SARLAT
Product code EZL
Product code name Catheter, Retention Type, Balloon

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Burst Container or Vessel, Pain, No Known Impact Or Consequence To Patient, Material Rupture, Failure to Deflate, Insufficient Information, Deflation 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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