MAUDE manufacturer profile

CONVATEC LTD · FRO

MAUDE profile for Dressing, Wound, Drug

Key facts

Manufacturer CONVATEC LTD
Manufacturer group CONVATEC
Product code FRO
Product code name Dressing, Wound, Drug

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
  • Delivered as Unsterile Product, No Clinical Signs, Symptoms or Conditions, No Patient Involvement, Contamination /Decontamination Problem, Unsealed Device Packaging, Device Contaminated During Manufacture or Shipping, Adverse Event Without Identified Device or Use Problem, Device Contamination with Chemical or Other Material 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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