Description of Event or Problem · 1
I BELIEVE THIS DEVICE MIGHT HAVE CAUSED MY MOM'S DEATH. FOR SEVERAL DAYS PRIOR TO MY MOTHER'S DEATH, SHE HAD A SHILEY#8 TRACHEOSTOMY TUBE INSERTED TO HELP HER BREATHE. SOMETHING WENT TERRIBLY WRONG AND SHE ACTUALLY BEGAN TO SPEAK WHILE THE TUBE WAS STILL INSERTED. I WAS CALLED TO THE HOSPITAL DUE TO HER CONDITION BUT WAS NOT PREPARED FOR WHAT I SAW. HER BODY AND FACE WERE SO SWOLLEN I ALMOST DID NOT RECOGNIZE HER. THE NURSES TOLD ME THAT SHE SUFFERED WHAT IS CALLED SUBCUTANEOUS EMPHYSEMA DUE TO THE TUBE. HER DOCTOR THEN TOLD ME THAT HE HAD NO EXPLANATION FOR WHAT HAD HAPPENED BUT THAT THE "TUBE WITHIN A TUBE" PART OF HER TRACH DEVICE HAD COME LOOSE AND PULLED OUT ON ITS OWN. HE REMOVED THE DEVICE AND HER THROAT BLED PROFUSELY. SHE DIED THREE DAYS LATER. I WROTE A LETTER TO (B)(6) (SHE WAS THERE WHEN THE INCIDENT TOOK PLACE BUT HER DOCTOR MOVED HER IMMEDIATELY BACK TO HER ORIGINAL HOSPITAL) AND TOLD THEM I FELT THEY HAD NOT BEEN DILIGENT IN THEIR MONITORING OF MY MOTHER BECAUSE THE NURSES SHOULD HAVE REALIZED THAT A PERSON CANNOT SPEAK WITH A TRACH TUBE INSERTED AND THEY SHOULD HAVE IMMEDIATELY REALIZED THERE WAS A PROBLEM. THEY OF COURSE CONTACTED ME AFTER THAT TO DENY ANY WRONGDOING. I HAVE INCLUDED A PHOTOCOPY OF THE SHORT NOTICE THAT APPEARED IN (B)(6) CONCERNING THE RECALL OF THE SHILEY BRAND TRACH TUBES. I KNOW I HAVE WAITED A LONG WHILE TO REPORT THIS TO THE FDA BUT I HAVE DECIDED THAT IT SHOULD BE REPORTED. I REALLY DON'T KNOW WHAT ANYONE CAN SAY TO ME ABOUT THIS MATTER BECAUSE MY MOTHER IS DECEASED. IT WAS HORRIBLE FOR ME TO SEE HER IN THAT CONDITION AND I CAN'T SEEM TO GET THE PICTURE OUT OF MY MIND. I WOULD APPRECIATE AN ACKNOWLEDGEMENT THAT SOMEONE AT THE FDA READ THIS LETTER.