inforMED
InjuryFIL

AVAULTA BIOSYNTHETIC SUPPORT SYSTEM

Received Nov 12, 2009

Report 1018233-2009-00128 · MDR key 3610024

Device

Model number

NA

Catalog number

486020

Lot number

UNK

Product problems

  • Material Erosion

Patient

UNK

  • Erosion
  • Extrusion
  • Surgical procedure, additional

Narrative

Description of Event or Problem

IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT FOLLOWING A POSTERIOR MESH PROCEDURE THE PATIENT HAS SUFFERED FROM EROSION, SHRINKAGE AND EXTRUSION OF MESH, URINARY RETENTION, SEVERE PAIN AND SURGICAL PROCEDURES TO REMOVE THE MESH.