Description of Event or Problem · 1
MY MOTHER WAS ADMITTED TO (B)(6) MEDICAL CENTER WITH ABDOMINAL PAIN AND WAS DIAGNOSED WITH A TOTAL OF 5 HERNIAS WHICH NEEDED ADDRESSING ON (B)(6), 2010. ON (B)(6), 2010, SHE WAS OPERATED BY TRAUMA SURGEON USING THE SO-CALLED KUGEL MESH - KUGEL MESH [MESH IS A MODIFIED KUGEL 5.4 X 7.0 LARGE OVAL. BARD (B)(4)]. THE MESH RUPTURED HER INTESTINE AND SHE WENT UNDER ANOTHER SURGERY ON (B)(6) WHEN SHE WAS ALREADY INTO SEPTIC SHOCK. THIS SURGERY REMOVED THE FRAGMENTS OF THE "MESH" AND WAS DONE PRIMARILY TO REPAIR HER INTESTINE. SHE WENT AGAIN UNDER SURGERY ON (B)(6) TO MAKE SURE INTESTINE HAD BEGUN HEALING. BECAUSE OF THESE 3 INTERVENTIONS, MY MOTHER ADDITIONALLY HAD TO BE ATTACHED TO VENTILATOR AND SUBSEQUENTLY A TRACHEOSTOMY WAS PERFORMED. MY MOTHER HAS NOT RECOVERED AND AFTER MORE THAN THREE MONTHS, BARELY CLINGS TO LIFE, HAS SUFFERED ENDLESS COMPLICATIONS INCLUDING A SORE THAT IS A STAGE-FOUR WOUND DUE TO THE FACT THAT SHE HAS NOT BEEN ABLE TO LEAVE HER BED ALL THESE MONTHS, A FISTULA THAT HAS NOT DRAINED, HAS LOST CONSIDERABLE WEIGHT, IS STILL ATTACHED TO A VENTILATOR AT (B)(6) MEDICAL CENTER AND HER HOPES FOR RECOVERY ARE DIM. THIS MEDICAL DEVICE MUST BE REMOVED FROM THE MARKET BEFORE IT CONTINUES TO AFFECT MORE PEOPLE IRREPARABLY. THE MAKER OF THE PRODUCT HAS NOT CHANGED THE STRUCTURE OF THE DEVICE AND KEEPS GETTING AWAY WITH RE-OFFERING THE DEVICE BY CHANGING DIMENSIONS. IT IS INCONCEIVABLE THAT THE FDA CONTINUES TO LET THIS MANUFACTURER PROCEED WITH AN ITEM THAT IS DESIGNED TO MALFUNCTION NO MATTER WHAT SIZE! FURTHERMORE, IF THIS MEDICAL DEVICE CONTINUES TO BE USED, PATIENTS SHOULD BE FULLY INFORMED THAT IT COULD EVENTUALLY TEAR, OR DAMAGE INTESTINAL AREA AND EVEN CAUSE DEATH!