FDA Adverse Event Other Summary report: N

PTFE GRAFT

MDR report key: 755367 · Received June 23, 2005

Report

Report Number
MW1035874
Event Type
Other
Date Received
June 23, 2005
Date of Event
November 1, 1997
Report Date
June 20, 2005
Manufacturer
ATRIUM MED
Product Code
DSY
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IMMEDIATELY UPON WAKING UP FROM THE SURGERY, THE NURSE ASKED IF I WAS ALLERGIC TO TAPE OR LATEX. NO, I REPLY. THIS WAS A FRIDAY MORNING AND I WAS IN THE HOSPITAL TILL THE FOLLOWING MONDAY THEN DISCHARGED THAT MORNING. I NOTICED AS I WASHED THAT I HAD VERY RED STREAKS ON MY BODY, NOT JUST ONE AREA AND THOUGHT MY SKIN REALLY DRY THIS TIME AFTER SURGERY. IT CONTINUED TO STAY RED BUT I WAS ON PAIN MEDICATION AND ASSUMED ALL THE PAIN WAS FROM SURGERY. AFTER STOPPING THE PAIN MEDICATION THE RED MARKS STARTED TO SWELL AND ITCH. I HAD THE HIVES. WHICH IS WHAT IT WAS ALL ALONG, JUST THAT THE DRUGS KEPT THE SWELLING AND WELTS FROM RISING. THE SURGEON DID NOT AGREE THAT IT WAS THE GRAFT. MY HEART DOCTOR DID BELIEVE THIS. I HAD SEVERE CASE OF HIVES. THIS LASTED FOR ALMOST A YEAR. I HAD TO TAKE STEROIDS (HEAVY DOSAGE AMOUNTS) FOR ALMOST A YEAR TO GET THE HIVES TO RELAX. THE HIVES ARE STILL THERE BUT ARE AT BAY SOME DAYS. MY SKIN IS VERY THIN AND MY ARM STAYS BRUISED WITH RED BLOOD BRUISES AS THOUGH I FALL OR SOMETHING ALL THE TIME. I CANNOT EAT CORN ON THE COB AS IT LOOKS AS THOUGH SOMEONE HAS PUNCHED ME IN THE MOUTH FROM THE PRESSURE OF THE CORN ON MY LIPS. IN OTHER WORDS I GET BRUISED. THIS IS THE SAME WITH A KISS TOO HARD, LAUGH OR PUT PRESSURE ON MY ARMS, JUST WRINGING HANDS. I NOW GET SOMETHING THAT LOOKS LIKE AN ALLERGY TO LATEX, WHICH THE GRAFT IS SUPPOSED TO BE LATEX FREE. BANDAIDS, AND SURGICAL TAPE JUST FROM I.V.'S LEAVES PURPLE BLOOD BRUISES ON MY ARMS OR LEGS. I CANNOT WEAR A BATHING SUIT VERY WELL ANYMORE BECAUSE IT HAS ELASTIC IN IT. I WILL GET THE RED HIVES. AND IF I AM OUT IN THE SUN WITH ONE ON MY SKIN UNDER THE SUITE GROIN AREA INCLUDED IS VERY RED. AND THIS IS ALL SINCE THE GRAFT. I KNOW IT HAS BEEN 8 YEARS SINCE THE GRAFT HAS BEEN PUT IN. BUT, THE FIRST YEAR WAS SPENT GOING TO DIFFERENT DOCTORS TO TRY AND TELL ME WHAT THE PROBLEM WAS. ONE DOCTOR WOULD LOOK AND SAY NO, GO HERE AND SO ON. THEY HAVE DETERMINED IT TO BE THE FOREGIN OBJECT IN MY BODY BECAUSE NOTHING ELSE DIFFERENT IN MY LIFE. AGAIN, I KNOW 8 YEARS HAS PASSED BUT I HAVE WRITTEN THE CLINIC, LAWYERS OVER WHAT TO DO AND NO ANSWERS. I HAVE NOT BEEN SITTING AROUND WAITING FOR TIME TO PASS UNTIL THIS GRAFT KILLS ME. I FELT I WAS LOOKING IN THE RIGHT PLACES TO DO SOMETHING. BUT I AM A LAYMAN NOT A PROFESSIONAL. AND EVERYWHERE I WENT THEY SAID NO AS IN LAWYER OR NEED PROOF. SO IT REALLY HAS TAKEN ME ALL THESE YEARS TO TRY AND GO ON MY OWN WITHOUT THE SYSTEM. I FINALLY GOT A LITTLE SMART ONLINE AND FOUND THIS FORM AND SINCE THE DOCTOR WOULD NEVER TELL ME ANYTHING ABOUT THE GRAFT. I FINALLY GOT A NURSE THERE TO TELL ME THE NAME OF IT AND TO CALL THE HOSPITAL AND SEE WHERE THEY ORDERED THEM FROM AND THAT IS HOW I GOT THE MFR OF THE GRAFT. I MAY BE SLOW GETTING THIS PUT TOGETHER, BUT IT IS A HUGE PROBLEM FOR ME AND MAYBE OTHERS. AND, IF THEY ARE GETTING WRITTEN OFF AS I AM AND SOMETHING NEEDS TO BE DONE. I UNDERSTAND THE ALLERGY TO THE GRAFT IS REALLY SLIM, BUT MY HISTORY SHOWS I FALL IN THE 1% PART OF LIFE. THIS HAS ALSO PUT A GREAT DEAL OF STRESS ON MY FAMILY AS THEY HAVE TO SEE ME SICK ALL THE TIME AND THEY HAVE TO TAKE ME TO DOCTORS TO HOPEFULLY GIVE ME AN ANSWER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PTFE GRAFT PLASTIC GRAFT FOR ARTERY DSY ATRIUM MED * *

Patients

Seq Age Sex Outcome Treatment
1 52 YR Other