inforMED
InjuryFHK

VESICA PERC STABILIZATION KIT WITH PROTEGEN SLING

Received Mar 11, 2004

Report 6000043-2004-00015 · MDR key 515383

Device

Generic name

Perc Stabilization Kit

Model number

NA

Catalog number

UNK

Lot number

UNK

Product problems

  • Explanted

Patient

NA

  • Erosion
  • Incontinence
  • Unspecified Infection
  • Surgical procedure

Narrative

Description of Event or Problem

IT WAS REPORTED THAT SUBSEQUENT TO THE IMPLANT OF A PROTEGEN SLING FOR TREATMENT IN 1998. THE PT BEGAN EXPERIENCING INFECTIONS AND EROSION THROUGH VAGINAL WALL IN SEPTEMBER OF 2003. THE SLING WAS REMOVED IN 2003. PT RETURNED TO EXPERIENCING INCONTINENCE.