CONFLUENT SPRAYSHIELD MAUDE Adverse Event Report

Another one!

CONFLUENT SPRAYSHIELD POLYMER KIT WITH SPRAYER SPRAYSHIELD KIT
Catalog Number SP10S01
Event Date 01/21/2011
Event Type Injury Patient Outcome Other;
Manufacturer Narrative
(b)(4).


Event Description
According to the reporter: the pt experienced heavy underbelly pains two days post-operatively. The pains were described as burning. At the fourth post-operative day, the stomach had to be re-opened. There were syrinxes that were discovered where the product had been applied, which were operated upon. The pt was released from the hospital free of pain.


Search Alerts/Recalls



New Search | Submit an Adverse Event Report

Brand Name SPRAYSHIELD POLYMER KIT WITH SPRAYER
Type of Device SPRAYSHIELD KIT
Manufacturer (Section F) CONFLUENT
101a first ave.
waltham MA 02451

Manufacturer (Section D) CONFLUENT
101a first ave.
waltham MA 02451

Manufacturer (Section G) CONFLUENT
101a first ave.

waltham MA 02451

Manufacturer Contact terry callahan
60 middletown ave.
north haven , CT 06473
(203) 492 -6273

Device Event Key 2070451
MDR Report Key 2037782
Event Key 1934758
Report Number 3003157248-2011-00007
Device Sequence Number 1
Product Code NQR
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/24/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 03/23/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number SP10S01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received 01/24/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2037782

Prevention of peritoneal adhesions: A promising role for gene therapy

More Good News for those who suffer from Adhesion Related Disorder!

Source: World J Gastroenterol


Prevention of peritoneal adhesions: A promising role for gene therapy; Atta HM; World Journal of Gastroenterology 17 (46), 5049-58 (Dec 2011)


Adhesions are the most frequent complication of abdominopelvic surgery, yet the extent of the problem, and its serious consequences, has not been adequately recognized. Adhesions evolved as a life-saving mechanism to limit the spread of intraperitoneal inflammatory conditions. Three different pathophysiological mechanisms can independently trigger adhesion formation. Mesothelial cell injury and loss during operations, tissue hypoxia and inflammation each promotes adhesion formation separately, and potentiate the effect of each other. Studies have repeatedly demonstrated that interruption of a single pathway does not completely prevent adhesion formation. This review summarizes the pathogenesis of adhesion formation and the results of single gene therapy interventions. It explores the promising role of combinatorial gene therapy and vector modifications for the prevention of adhesion formation in order to stimulate new ideas and encourage rapid advancements in this field.

http://www.docguide.com/prevention-peritoneal-adhesions-promising-role-gene-therapy?tsid=5

Breaking News! Adhesions easily visualised with simple Barium Swallow!

Breaking News!

Adhesions easily visualised with simple

 "NONE INVASIVE "

CONTRAST X-RAY BARIUM SWALLOW!

When taking the test, you drink a preparation containing Barium sulfate . The x-ray tracks the chalky like liquid as it makes it way through your digestive system, (inside the organs).....however it also showed what was on the OUTSIDE of the organs of the digestive track, (in the peritoneal cavity within the abdominal cavity!)

The "Contrast Barium Swallow" abdominal x-ray diagnostic  was never meant to show anything else, it showed ADHESIONS attaching internal organs in the lower digestive track to the peritoneum and to other organs.

It can also show the "mis-alignment" of intestines from being pulled out of the normal alignment by adhesion attachments!

This diagnostic can also detect bowel obstructions or bowel impactions---and all of this without so much as a surgeons knife!

 

MORE TO COME
on this magnificent discovery in the world of
ARD!

Maybe 2012 WILL be a year of good for

"Adhesion Related Disorder"
victims!

!!!! Visible Adhesions !!!!!

"MERRY CHRISTMAS"
"HAppy Holidays"
or rather
"THank-God"

!! DEMAND THIS DIAGNOSTIC !!

The "X-Ray Barium Swallow" diagnostic test is NOT used to detect adhesions, or any other "pathological anomalies," OUTSIDE of the organs of the digestive track! 

The "X-Ray Barium Swallow" is a diagnostic tool used to solely  detect "pathological anomalies, obstructions and/or diseases," WITHIN the organs of the digestive track!

You MUST insist that your attending physician order this diagnostic test if you have had a previous adhesiolysis, or many of them for that matter, and are currently experiencing abdominal/pelvic pain that YOU think is associated with adhesions, or ARD!

Have it ordered for "Pain," as you see listed below!

DO NOT ALLOW YOURSELF

to be denied this diagnostic!

Barium Swallow IntroductionA barium swallow is a test that may be used to determine the cause of painful swallowing, difficulty with swallowing, abdominal pain, bloodstained vomit, or unexplained weight loss.

Barium sulfate is a metallic compound that shows up on x-ray and is used to help see abnormalities in the esophagus and stomach. When taking the test, you drink a preparation containing this solution. The x-rays track its path through your digestive system.

•These problems can be detected with a barium swallow: ◦Narrowing or irritation of the esophagus (the muscular tube between the back of the throat and the stomach)

◦Disorders of swallowing

◦Hiatal hernia (an internal defect that causes the stomach to slide partially into the chest)

◦Abnormally enlarged veins in the esophagus that cause bleeding

◦Ulcers

◦Tumors

◦Polyps (growths that are usually not cancerous, but could be precancerous)

Barium Swallow - Test Results

ALWAYS INSIST YOU RECEIVE A COPY OF THE TEST , BUT MOST IMPORTANT IS THAT YOU SECURE A VISUAL COPY OF THE FILMS OF THE X-RAY ITSELF AS IT IS IN THESE THAT YOU WILL SEE ADHESIONS IF THEY ARE VISIBLE!!!!

The "normal" pathology results your Dr. looks for and will jabber about are listed below here, just listen them out, then make sure you get a visual or the test for yourself! It is imperative that YOU look for your own results and IF adhesions can be seen in these films, you will recognize them!

Usual Test Results:
Ask your doctor for the results of your barium swallow test. You may have to wait a few days until the radiologist (a specialist in x-ray examinations) looks at the x-rays and gives your doctor the final results. Your doctor will recommend a plan of action to you based on the results.

•The x-rays will show the digestive wave (peristalsis) through the length of the esophagus. When barium reaches the end of the esophagus, the barium enters the stomach.
•The barium swallow may reveal problems in the pharynx (the back of the throat), the esophagus, or the stomach. The problems could be narrowing, tumors, polyps, ulcers (erosions), or disorders in moving food through the system. It can also show a hiatal hernia, diverticula (pouches opening along the esophagus), or varices (enlarged veins).

•If the barium swallow test shows any area of concern, your doctor may plan what other tests, procedures, treatments, or medications you may need. The treatment for problems discovered during a barium swallow vary depending on the condition.  http://www.emedicinehealth.com/barium_swallow/article_em.htm

 

A picture is worth a 1000 word...so see for yourselves!

In 2009 a known adhesion sufferer had a GI Barium Swallow for "Chronic Abdominal Pain."

This female suffered "Adhesion Related Disorder" and had undergone multiple surgeries in which abdominal adhesion's were present and lysed in each of her each surgeries.  Relief was always fleeting and the pain always returned after each surgery.

When this test was taken in 2009 she was told everything is fine and the test revealed nothing, and it was absolutely right, as long as he made his determination based on what the test was meant to show! She had NO abnormal internal organ pathology showing in this Barium Swallow!  The docs said she was just fine and sent her on her way.

She had Cat scans, MRI's every test in the book, you name it and the financial toll was enormous...... and all the doctors said she was fine. They could find nothing wrong and yet she suffered so.
A subsequent surgery was scheduled and records and imagery were sent to the new surgeon.

During pre op...reviews of all the tests...these images below caught the surgeon eye!
The surgeon palpitated each area where adhesions were being visualised on these simple

 "Contrast Barium Swallow X-Ray Films."
As an ARD patient advocate watched, knowing what was being seen on the screen in front of them showing what could only be "ADHESIONS," the Dr. asked the patient, "Does it hurt there? Does it hurt here?"

 Each time the ARD patient confirmed her pain was exactly where the surgeon indicated it might be in her abdomen. The surgeon then told his surgery team that he wanted these films up on a screen in the operating room during the procedure!
 

 You bet he did!

An IHRT patient advocate was scrubbed up and in the OR with the surgeon.....as you will see below, everywhere the wispy white tendrils appeared...is where he lysed adhesion! He used the images below as a guide to lysing the patients adhesions during the entire surgery. He confirmed this for us all!

After surgery, the patient, the surgeon and IHRT advocate were in somewhat of disbelief at what they had just witnessed, and they knew that these images had guided the way...the surgeon confirmed for us that indeed...this simple test reveled adhesions exquisitely!

We feel that this may finally be the end of expensive testing for adhesion patients....the statement that adhesions rarely if ever show up in any type of imaging is now a myth.
No more "Let's have a surgical look, see" to search for the always elusive adhesions.
Use these images to advocate for yourself. Ask for this simple non invasive, inexpensive test!!!!
It is not in your head....it is right there in black and white for all the world to see.
Removing personal information from these images has been difficult but this most generous adhesion sufferer has had that as her only request.
There are more images still to be placed in this posting and each image will be summarised  as to what you are looking at anatomically so please check back! Approx a dozen more images from the same series coming soon!

This news is so wonderful we wanted to get it to you as soon as possible!
We wish all who suffer from adhesions all the best this holiday season and we present you a gift from an anonymous adhesion sufferer.

A simple " Contrast Barium Swallow X-Ray!"

"MERRY CHRISTMAS"
"Happy Holidays"

Surgery done by Dr Pagels



We place his information here for your convenience but urge you to exercise due diligence when deciding which surgeon is right for you!


Dr. Pagels is now Chief of Gynecology at St.Josef Krankenhaus Moers. He was chief of Gynecology at Klinikum Duisburg, when this surgery was done.
This is his address: Herr Dr. Med. Jens Pagels
St. Josef Krankenhaus Moers
Asberger Str. 4
47441 Moers
Germany
Telephone Number: +49 (0) 2841 1072430
His email address is: gyn.pagels@st-josef-moer



This first image below ...what do you see in the one o'clock position?

Do YOU think you are correct!
( NO, that is not a fetus, it is a twisted bowel!)

A Personal Case for Classical Homeopathy, Part I

Exerpt from :A Personal Case for Classical Homeopathy, Part I
Judith Acosta





Many years ago, I suddenly developed abdominal pain. I had not been sick in any other way and had no idea what was happening. I went for a gynecological exam and was told I was fine. The pain continued. I went back and after numerous exams was sent from the table to the couch. The psychiatrist sent me right back to the doctor. After about a year of bouncing back and forth with increasingly intense (searing, stabbing) pain, they finally "discovered" a mass several centimeters in width in the area of my left ovary.

At this point, the surgeons were called in. I was scheduled for an emergency laparotomy. As they wheeled me in, the surgeon said to my mother, "It could be cancer." I was 26.

After surgery, as soon as I stopped vomiting, the doctor told me that it was not cancer. My mother wept. He said it was a streptococcal infection (Strep B) that had created adhesions and that I could forget about having children. He proudly went on to inform us that they had "scraped me clean" and that I'd be on antibiotics for about a month.

I did as I was told. I was raised by a doctor, surrounded by doctors and had complete faith in the system.

Within a short time a whole new sort of pain emerged, this time, however, deeper. It was more localized, again on the left side. I thought the infection had returned. The pain continued for quite a while. I went to the doctor, but there was no infection. After dismissing it (and me) for at least a year again, I finally wound up in hospital. A cyst had burst. This cycle recurred every few months. They recommended birth control pills, pain pills and pills I didn't understand. Nothing helped. By the fourth rupture and hospital visit, they recommended a full hysterectomy.
Read the entire article here: http://www.huffingtonpost.com/judith-acosta/homeopathy_b_1150591.html

Please stand by for World Wide Breaking News ~ The day that changes Adhesion Related Disorder forever

We will be bringing you the story that will change the lives of those suffering from Adhesion Related Disorder forever.

This news will empower you to advocate for yourself and never again be told,

"It's all in your head!"

Behind the badge with Sheriff Stephens ~ "Back then, they called it heartburn!"

Exerpt from full article: http://www.forest-blade.com/news/community/article_f9faf6aa-25d4-11e1-bbc7-0019bb2963f4.html

In the past year, however, Stephens has faced medical difficulties that made it difficult to keep pace with his many obligations. Twenty-three years ago, Stephens was diagnosed with esophageal cancer as a result of acid reflux disease. Though he's been cancer-free since then, the surgery did lasting damage.


"Back then, they called it heartburn!" he says. "They caught it early and they were able to remove the cancer fully. Through the years, the surgery caused a lot of different problems, and I've had my share of them, but I began to have trouble digesting food and it kept getting worse until this year, when I had to have serious surgery to reconstruct my digestive system."


The surgery has solved a lot of Stephens's problems with adhesions and scar tissue from previous surgeries and he is back on his feet and recovering well.


"I was blessed to get through it. It was a tough time for me and for my department," he says. "I can't say enough good words about my employees. They carried on and never missed a lick while I was down recovering from that major surgery."

What is ovarian remnant syndrome?

Q:What is ovarian remnant syndrome?

A: Ovarian remnant syndrome (ORS) occurs if any ovarian tissue is left after surgery to remove both ovaries and fallopian tubes, called a bilateral salpingo-oophorectomy. The syndrome occurs if this ovarian tissue causes severe pelvic pain and/or a pelvic mass.

The condition typically occurs because of the surgical technique used to remove the ovaries. Although ORS is considered fairly rare, its incidence appears to have increased in the past 40 years, possibly related to the increased use of laparoscopic surgeries.These surgeries allow the surgeon to operate through two or three tiny incisions instead of a large abdominal incision.

Certain factors increase the risk of incomplete ovarian removal, including a history of endometriosis, pelvic inflammatory disease, previous abdominal or pelvic surgeries and pelvic adhesions. Adhesions are scar tissue that forms after pelvic or abdominal surgery and "sticks" to organs and other tissue. Adhesions make it difficult for the surgeon to completely identify and remove the ovaries because of the fibrous tissue that binds an ovary with the other structures or with the peritoneum, the membrane that covers the inside of the abdomen and pelvis.

If any ovarian tissue is left in your pelvis, it can, in some instances, continue to produce hormones.

The most common symptoms of ovarian remnant syndrome are constant, chronic pelvic pain, difficult or painful intercourse, cyclic pelvic pain, and painful urination and bowel movements.

The condition is diagnosed based on a careful medical history. One sign that there may be residual ovarian tissue is if after your ovaries were removed, you didn't immediately start hormone therapy but didn't experience menopausal symptoms, such as hot flashes. This would suggest that you may still be producing estrogens. An alternative situation is if after surgery, you started hormone therapy and then discontinued it for some reason but didn't experience these symptoms.

Your doctor may also perform an ultrasound, CT scan or MRI to identify any ovarian tissue or pelvic mass and may measure blood levels of follicle-stimulating hormone (FSH) and estradiol. Estradiol is produced by the ovaries and FSH by the pituitary gland in response to hormonal signals from the ovaries. Levels of estradiol should be very low and levels of FSH should be very high after both ovaries have been removed.

If your doctor does find ovarian tissue remnants, you may be treated with medication to suppress any ovarian function, surgery to remove the tissue, or, as a last resort, radiation to destroy the tissue.

http://www.healthywomen.org/content/ask-expert/1761/ovarian-remnant-syndrome?context=womentalk/ask-the-expert&context_title=ask-the-expert