MAUDE manufacturer profile

BARD SHANNON LIMITED · OTO

MAUDE profile for Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Key facts

Manufacturer BARD SHANNON LIMITED
Manufacturer group C.R. BARD, INC. (COVINGTON) -1018233
Product code OTO
Product code name Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Incontinence, Injury, Internal Organ Perforation, Urinary Retention, Urinary Tract Infection, Fever, Disability 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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