MAUDE manufacturer profile

ABISS - ANALYTIC BIOSURGICAL SOLUTIONS · OTN

MAUDE profile for Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Key facts

Manufacturer ABISS - ANALYTIC BIOSURGICAL SOLUTIONS
Manufacturer group MINNEAPOLIS
Product code OTN
Product code name Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Pain, Adverse Event Without Identified Device or Use Problem, Erosion, Urinary Tract Infection, Urinary Incontinence, Micturition Urgency, Dyspareunia, Urinary Retention 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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