Posts Tagged ‘ MAUDE Database ’

How to Post an Adverse Event with the FDA

Aug 30th, 2015 | By
Pacemaker, Courtesy WikiCommons, Steven Fruitsmaak

MND, August 30, 2015 ~When you have a new car that develops a “safety” issue i.e. braking, steering, airbags, wiring, engine cooling, unintended acceleration etc, the auto dealer reports the problems to the manufacturer, who by law, must report the issue to the National Highway Traffic Safety Administration within five days. But when a patient
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Your Turn: After the Ethicon decision

Feb 19th, 2014 | By
Anonymous woman, WikiCommons

This woman who will go unnamed has written her thoughts about the Charleston decision regarding the TVT implant and the judge’s decision to cut short a jury decision and to make the decision on his own.   She admits she was frustrated and it was 3 am but she felt better afterward.  As the only reporter
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Find Your Mesh in the 510(k) Process

Nov 21st, 2013 | By
Prolene mesh

For those readers who want to know more about the mesh they may have had implanted for pelvic organ prolapse, stress urinary incontinence or hernia, the process is made easier if you have the Medical Device approval number from the FDA. Below is a handy list of 510(k) approvals which you must look up under
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FDA Asks Consumers to Report Product Failures

Jun 10th, 2013 | By
FDA medwatch form 200

June 10, 2013 ~ New and Improved? The U.S. Food and Drug Administration (FDA) is celebrating 20 years of the MedWatch program by providing consumers with a new form that should encourage consumers and medical professionals to report adverse events, complications and bad outcomes with drugs and medical devices, cosmetics, medical equipment, food or supplements.
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FDA Workshop on Health of Women

Apr 9th, 2013 | By
D20proliftm graphic  he wrote it

April 9, 2013 ~ According to a new page on the FDA’s website (here), a public workshop will be held on HoW to Improve the Health of Women (HoW).  The purpose is to delve into how some medical devices work differently in women than men. It’s been noted that some hip implants have an early
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Day 8: Linda Gross v Ethicon, Prolift Launched Under FDA Radar

Jan 22nd, 2013 | By
Dr. Peggy Pence, Courtesy CVN

January 22, 2013 ~ Much thanks to Courtroom View Network for access to the live court proceedings and graphics shown to the jury. The Prolift surgical mesh did not undergo any FDA approval before it was marketed in March 2005. Last June Ethicon, a division of Johnson & Johnson announced it was removing Prolift and
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Hernia Mesh Complications- Is the FDA Watching? Part II

Nov 28th, 2012 | By
Dr. Kevin Petersen, YouTube, No Insurance Surgery

November 28, 2012 ~ Continuation from Part I, According to hernia mesh removal surgeon, Dr. Kevin Petersen, in a certain percentage of patients, the body will detect hernia mesh as a foreign material and will reject it. Symptoms may include scar tissue that leads to chronic pain and causes mesh to shrink and shrivel up,
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Dollars and Sense? Saving Money on Hernia Mesh

Sep 17th, 2012 | By
Money graphic, WikiCommons

  “Application of Evidence-Based Value Analysis: Standardization of Surgical Mesh Products” In this White Paper, Winifred Hayes, a medical efficiency analyst, known as, “Your Outsourced Research Partner,” tells hospitals how to save money buying hernia mesh by being more efficient. Problem: In the case of hernia mesh, hospitals buy mesh from a limited number of
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Consumers Union on Improving the Safety of Medical Devices

Feb 8th, 2012 | By

  Improve the safety of medical devices An overview of Consumers Union’s Safe Patient Project Initiative Medical devices, like eyeglasses and contact lenses, are a part of our everyday lives and are a growing part of the health care we receive. Complex devices like artificial hip joints, surgical mesh, and cardiovascular stents, are permanently implanted
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