InjuryFHK
SPARC SLING SYSTEMS
Received Aug 3, 2004 · Event occurred Jul 1, 2004
Report 2183959-2004-00031 · MDR key 537847
Device
Generic name
Sparc/other Sling Types
Manufacturer
American Medical Systems, Inc.Model number
72403830Catalog number
NA
Lot number
NI
Product problems
- Break
- Implant extrusion
Patient
NO INFO
- Foreign body, removal of
Narrative
Description of Event or Problem
A PT WAS AT THE DOCTOR'S OFFICE FOR A FOLLOW-UP VISIT AFTER A MONARC SLING SYSTEM PROCEDURE. THE DOCTOR DETERMINED THE SLING WAS EXTRUDING THROUGH THE VAGINAL WALL. THE DOCTOR BELIEVES THAT A SUTURE GAVE WAY AND THE SLING THEN PROTRUDED THROUGH THE VAGINAL INCISION AND THE PT HEALED WITH PART OF THE SLING OUTSIDE THE VAGINAL WALL. THE DOCTOR REMOVED THE PORTION OF THE SLING THAT WAS PROTRUDING.