Description of Event or Problem · 1
MS (B)(6) HAS ASKED ME TO REPORT TO THE FDA "HER ADVERSE REACTION" TO PROLENE MESH USED IN THE REPAIR OF HER RIGHT INGUINAL HERNIA (B)(6) 2008. I HAVE NOT SEEN HER; INVESTIGATED HER OR TREATED HER FOR THIS PROBLEM. THEREFORE, I CANNOT COMMENT ON HER "ADVERSE REACTION." MS (B)(6) AND HER DOCTORS IN (B)(6) WILL HAVE TO "REPORT ANY ADVERSE REACTIONS," IF THEY EXIST AND ARE RELATED TO THE PROLENE MESH. I CAN REPORT THAT IN 2008, MS (B)(6) WAS REFERRED TO ME BY HER GASTROENTEROLOGIST AND HER G.P. BECAUSE SHE HAD SYMPTOMATIC PAINFUL RIGHT INGUINAL HERNIA. THIS WAS INVESTIGATED AND SURGICALLY TREATED BY ME. IT WAS A REPAIR OF A RIGHT INGUINAL HERNIA WITH A PROLENE PLUG AND MESH TECHNIQUE. ON (B)(6) 2008, POST-OPERATION THE PT DID WELL AND RECOVERED FROM THE SURGERY WITHOUT ANY COMPLAINTS. I LAST SAW HER ON (B)(6) 2008. I HAVE NOT SEEN HER OR TREATED SINCE. INFO FOR THE PROLENE MESH USED IN HER SURGERY IS: BARD MESH PERFIX PLUG, SIZE LARGE, REF NUMBER 0112770, LOT NUMBER HUSB 1789. IF YOU WISH I CAN SEND YOU DETAILS OF ALL PRE-SURGERY INVESTIGATION AND REPORTS THAT I HAVE ON FILE. IF MORE INFO IS REQUIRED ABOUT HER ADVERSE REACTION HER OTHER DOCTORS IN TORONTO WILL BE ABLE TO SUPPLY THIS ADD'L INFO. THEIR NAMES AND CONTACT INFO WILL BE PROVIDED BY MS (B)(6) I WISH MS (B)(6) A FULL AND EARLY RECOVERY. (B)(6). DATE OF USE: (B)(6) 2008 TO PRESENT. DIAGNOSIS OR REASON FOR USE: SYMPTOMATIC PAINFUL RIGHT INGUINAL HERNIA.