Description of Event or Problem · 1
MY MOTHER HAD ONGOING ABDOMINAL PAIN ON (B)(6) 2011. SHE HAD AN OPERATION: LAPAROSCOPIC LYSIS OF ADHESIONS WHERE THE PREVIOUS GORE-TEX DUAL MESH INFECTION HAD BEEN REMOVED. MY MOTHER (B)(6) HAD A HERNIA GORE-TEX DUAL MESH PUT IN (B)(6) 2007 WHICH BECAME INFECTED. ON (B)(6) 2007, IT WAS REMOVED BUT SHE CONTINUED TO HAVE PAIN IN THE ABDOMINAL AREA. HER PAIN GOT WORSE AS TIME WENT BY. ON (B)(6) 2011, SHE HAD LAPAROSCOPIC LYSIS OF ADHESIONS SURGERY ON THE SAME AREA WHERE DEFECTED MESH WAS REMOVED. SHE WAS IN THE HOSPITAL FROM (B)(6) 2011 THEN BACK ON (B)(6) 2011 UNTIL (B)(6) 2012. ON (B)(6) 2011, MULTIPLE ABSCESSES WERE FOUND ON INTESTINES AND ANOTHER MORE INVASIVE SURGERY WAS DONE ON (B)(6) 2011. MY MOTHER ENDED UP WITH A FISTULA WHICH COULDN'T BE REPAIRED DUE TO HER AGE PER DOCTOR. ON (B)(6) 2011, SHE WENT INTO CARDIAC ARREST. WE ENDED UP WITH HOSPITAL HOSPICE CARE UNTIL GOD TOOK HER TO BE WITH HIM. I STRONGLY FEEL THAT ALL CAME FROM THE DEFECTIVE GORE-TEX DUAL MESH. I SPOKE TO (B)(4) (PRODUCT SURVEILLANCE COORDINATOR) FROM W.L. GORE & ASSOCIATES, INC. ABOUT THIS MATTER. I HAVE NOT SENT ANY INFORMATION TO THIS COMPANY. I FELT IT SHOULD BE SENT TO MEDWATCH. THANKS, (B)(6). CAUSE OF DEATH PER AUTOPSY EXAM: BRONCHOPNEUMONIA AND SEPSIS SECONDARY TO COMPLICATIONS OF PRIOR LAPAROSCOPIC SURGERY.