MAUDE manufacturer profile

HOLLISTER INCORPORATED · GBM

MAUDE profile for Catheter, Urethral

Key facts

Manufacturer HOLLISTER INCORPORATED
Manufacturer group HOLLISTER ULC
Product code GBM
Product code name Catheter, Urethral

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Urinary Tract Infection, Adverse Event Without Identified Device or Use Problem, Insufficient Information, Patient Device Interaction Problem, Hematuria, Hemorrhage/Blood Loss/Bleeding, Difficult to Insert, Material Twisted/Bent 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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