MAUDE manufacturer profile

UNOMEDICAL S.R.O. · FON

MAUDE profile for Bag, Drainage, With Adhesive, Ostomy

Key facts

Manufacturer UNOMEDICAL S.R.O.
Manufacturer group UNOMEDICAL S.R.O.
Product code FON
Product code name Bag, Drainage, With Adhesive, Ostomy

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Hemorrhage/Blood Loss/Bleeding, Erythema, Adverse Event Without Identified Device or Use Problem, Improper or Incorrect Procedure or Method, Ulcer, Pressure Sores, Off-Label Use, Sharp Edges 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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