Description of Event or Problem · 1
ON (B)(6)2005, I WAS ADMITTED AT (B)(6) HOSPITAL'S EMERGENCY ROOM IN (B)(6) DUE TO CHRONIC LOW BACK PAIN RELATED TO PREVIOUS DIAGNOSIS OF HERNIATED DISK AT L5-S1 SPINAL VERTEBRAL. THEN ON (B)(6) 2005 WITH MEDICAL RECORD # (B)(6) WAS ADMITTED FOR INTERLAMINAR DISCECTOMY SURGERY THAT WAS PERFORMED BY DR. (B)(6) (NEUROSURGERY). AFTER A MONTH OF POST SURGERY I STARTED TO DEVELOP PAIN AROUND THE SURGERY AREA, AFTER VARIOUS EXAMS AND TESTS I WAS READMITTED ON (B)(6) 2005 DUE TO CHRONIC PANIC FOR VERTEBRAL OSTEOMYELITIS. AFTER THIS DIAGNOSIS I HAD AN INTRAVENOUS ANTIBIOTICS TREATMENT FOR 43 DAYS. A LOT OF THEORIES CAME OUT OF WHAT CAUSED THIS INFECTION DURING MY SURGERY (I WAS INFORMED THAT THERE WERE MORE THAN INFECTIONS DURING THAT WEEK OF MY SURGERY), THE MOST COMMON ONE WAS THAT THE INSTRUMENTS WERE NOT WELL STERILIZED. SINCE THAT DATE I HAVE INVESTIGATED AND FOUND THAT THE MAJOR SUPPLIER OF SURGICAL KITS WAS THE COMPANY (B)(4) AND ITS DISTRIBUTOR (B)(6) COULD HAVE SOLD THESE ADULTERATED OR NON CONFORMANCE PRODUCT TO THEIR CLIENTS INCLUDING (B)(6) HOSPITAL IN (B)(6). THERE IS AN FDA WARNING LETTER SNJ-05-07 DATED JUNE 22, 2005, WHERE THE FDA INVESTIGATED FOUND A LOT OF DISCREPANCIES. IMPORTANT EMPHASIZE THAT THIS COMPANY (B)(4), HAD TOO MANY QUALITY ISSUES PRIOR TO THIS DATE AND THERE IS ONE STILL ACTIVE DUE TO THE SAME PROBLEM OF MAINTAINED "CGMP". I HAVE CONTACTED THE (B)(6) HOSPITAL BECAUSE I AM LOOKING FOR THE CATALOG AND LOT NUMBERS OF ALL THE MEDICAL DEVICE PRODUCTS USED DURING MY SURGERY. I HAD COPY OF MY RECORD BUT IT HAS BEEN VERY DIFFICULT TO FIND THAT IMPORTANT INFO ON MY RECORD'S COPY. AS OF TODAY, I AM STILL SUFFERING AFTER-EFFECTS OF THIS PROBLEM. I WILL HOPE WITH THIS VOLUNTARY REPORT THAT FDA MAY CONDUCT AN INVESTIGATION TO FIND ROOT CAUSE OF THIS CRITICAL PROBLEM, ALSO FIND A WAY TO DEMAND OR ENCOURAGE MEDICAL FACILITIES TO INCLUDE CATALOG AND LOT OF PRODUCTS THAT THEY USED IN EACH SURGERY OR TREATMENTS. THANK YOU VERY MUCH!