InjuryFHK
SPARC SLING SYSTEMS
Received Nov 12, 2004 · Event occurred Aug 27, 2004
Report 2183959-2004-00047 · MDR key 555760
Device
Generic name
Sparc/other Sling Types
Manufacturer
American Medical Systems, Inc.Model number
NACatalog number
NA
Lot number
363861004
Product problems
- Explanted
Patient
NO INFO
- Pain
- Surgical procedure
Narrative
Description of Event or Problem
A SPARC SLING WAS ERODED INTO THE VAGINA. IN 04/2004 THE DOCTOR PUSHED THE SLING UP AND FLATTENED IT DUE TO ITS TWISTED STATE. THE SLING HAD TWISTED AND THE EDGE OF THE SLING WAS PUSHING INTO THE VAGINAL WALL. THE DOCTOR PLACED SUTURES TO KEEP IT FLATTENED. DUE TO SEVERE PAIN IN THE GROIN AND VAGINA AREA THE DOCTOR LOOSENED SOME OF THE STITCHES A WEEK LATER. DUE TO PAIN THE DOCTOR REMOVED THE SLING IN ABOUT 4 MONTHS. THE PT CONTINUED TO COMPLAIN OF PAIN AFTER THE SLING REMOVAL.