MAUDE manufacturer profile

W. L. GORE & ASSOCIATES, INC. · OXF

MAUDE profile for Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

Key facts

Manufacturer W. L. GORE & ASSOCIATES, INC.
Manufacturer group MPD APC B/P
Product code OXF
Product code name Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

At a glance

  • 1–9 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Seroma, Unspecified Infection, Microbial Contamination of Device, Material Separation, Insufficient Information, Adverse Event Without Identified Device or Use Problem 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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