inforMED
InjuryMCA

BOSTON SCIENTIFIC

Received Jan 14, 2011 · Event occurred Mar 9, 2010

Report MW5019061 · MDR key 1969284

Device

Generic name

Advantage Fit Transvaginal Tape

Manufacturer

Boston Scientific

Model number

ADVANTAGE FIT

Catalog number

850-2110

Lot number

OML9092101

Product problems

  • Insufficient Device Problem Information

Patient

62 YR

  • Unspecified Infection
  • Muscle Spasm(s)
  • Pain
  • Discomfort

Narrative

Description of Event or Problem

I HAD TVT BLADDER SLING SURGERY IN (B)(6) 2010, AND IMMEDIATELY NOTICED A PULL IN MY GROIN. I HAD A CATHETER REMAIN IN MY BODY WITH SERIOUS INFECTIONS FOR NINE WEEKS UNTIL A SECOND SURGERY WAS PERFORMED (B)(6), 2010, TO CUT THE MESH. IT TOOK SEVERAL WEEKS OF SELF CATH AND BLADDER SPASMS BEFORE I GAINED USE OF MY BLADDER BUT I AM STILL INCONTINENT. SINCE THE SECOND SURGERY, LEG AND THIGH PAIN INCREASED OVER MONTHS AND MOVED INTO MY HIP AND BUTTOCKS. I NOW USE A WALKING STICK TO WALK. I HAD AN EMG WHICH DID NOT SHOW ANYTHING, BUT I CANNOT AFFORD MORE TESTS AS I DO NOT HAVE INSURANCE. I AM IN CONSTANT PAIN EVERY DAY AND THIS HAS STOPPED ME WORKING OR BEING PRODUCTIVE. I AM A CRIPPLE FROM THIS PRODUCT.