Description of Event or Problem · 1
I HAD SURGERY IN 2008. I HAD A KUGEL MESH PLACED AT THAT TIME FOR PREVENTION OF FUTURE HERNIA. I BEGAN HAVING PAIN IN EARLY 2007. I HAD A CT IN THE ER OF HOSPITAL. I WAS TOLD THERE WAS NOTHING WRONG. I FOLLOWED UP WITH MY GI TELLING HIM OF THE PAIN AND SWELLING. HE REVIEWED THE CT AND SENT ME BACK TO MY SURGEON. I WENT AND SAW HIM IN FIVE MONTHS AFTER THE ORIGINAL DATE. HE REVIEWED MY CT AND REPORTED TO ME THAT MY MESH WAS NOT LAYING FLAT AND IT WOULD HAVE TO COME OUT. HE TOLD ME THE RING COULD BREAK, BUT THAT I DID NOT HAVE TO HAVE THE SURGERY NOW, BUT WE SHOULD CONSIDER IT IN THE FUTURE. MY PAIN AND SWELLING CONTINUED. I DECIDED I COULD NOT TAKE THE PAIN ANYMORE. I AM TAKING VERY STRONG PAIN MEDICATION. THE PAIN AND SWELLING INTERFERE WITH MY DAILY LIVING, AND MY ABILITY TO MAINTAIN A JOB OR GET ONE BECAUSE OF MY USE OF PAIN MEDICATION. I SPOKE WITH MY SURGEON'S PA. DR IS THE SURGEON, HE WAS ON VACATION. WE DECIDED THE DEVICE WOULD NEED TO COME OUT AND WOULD SCHEDULE MY SURGERY THE WEEK AFTER DR RETURNED FOR VACATION. I AM CURRENTLY SCHEDULED FOR SURGERY TWO MONTHS LATER. I HAVE SINCE LEARNED MY MEDICAL RECORD DOES NOT CONTAIN THE LOT NUMBER OR ANY OTHER DOCUMENTATION ON MY KUGEL MESH. THE HOSPITAL HAS AGREED TO PAY FOR MY SURGERY AND STATED MY MESH IS ON RECALL BY THE FDA. I SPOKE TO THE RISK MANAGEMENT DEPT AND THEY SAY THEY DO NOT KNOW WHY I WAS NOT CONTACTED ABOUT THE RECALL. DATES OF USE: 2004-2008. DIAGNOSIS OR REASON FOR USE: PREVENTION OF FUTURE HERNIAS.