InjuryFHK
SPARC SLING SYSTEM
Received May 15, 2012
Report 2183959-2012-00630 · MDR key 2581243
Device
Generic name
Surgical Mesh
Manufacturer
American Medical Systems, Inc.Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Erosion
- Emotional Changes
- Incontinence
- Pain
- Scarring
- Injury
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED THE PT WAS IMPLANTED WITH A SPARC SLING SYSTEM AND ANOTHER MANUFACTURER'S MESH ON OR ABOUT (B)(6) 2002 TO REVISE/REPAIR A PREVIOUS MESH DEVICE (ANOTHER MANUFACTURER'S MESH DEVICE) THAT WAS IMPLANTED ON OR ABOUT (B)(6) 2000. THE PT EXPERIENCED MENTAL AND PHYSICAL PAIN AND SUFFERING, DYSPAREUNIA, VAGINAL AND MESH EROSION, HARDENING, DENSE SCARRING, RECURRENT INCONTINENCE, AND PERMANENT INJURY. THE PT UNDERWENT NON-SPECIFIED SURGERY.
Additional Manufacturer Narrative
SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.