MAUDE Database

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FDA Says it’s Taken 21,000 reports of Wen Hair Care Complaints

Mesh News Desk, July 20, 2016 ~ The U.S. Food and Drug Administration says it has received 127 adverse event reports about the WEN Hair products. Promoted on television by celebrity stylist, Chaz Dean, the FDA says his office has received 21,000 complaints. Complaints include reports of balding, rashes and Read more

By | 2016-07-20T14:06:42+00:00 July 20th, 2016|FDA News|7 Comments

How to Post an Adverse Event with the FDA

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 Read more

By | 2015-08-30T00:00:00+00:00 August 30th, 2015|FDA News|23 Comments

Your Turn: After the Ethicon decision

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 Read more

By | 2014-02-19T12:43:00+00:00 February 19th, 2014|Your Turn|42 Comments

Find Your Mesh in the 510(k) Process

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 Read more

By | 2013-11-21T14:10:30+00:00 November 21st, 2013|Mesh Reading Room Resource|9 Comments

FDA Asks Consumers to Report Product Failures

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, Read more

By | 2013-06-10T16:07:02+00:00 June 10th, 2013|FDA News|4 Comments

Day 8: Linda Gross v Ethicon, Prolift Launched Under FDA Radar

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, Read more

By | 2013-01-22T23:07:59+00:00 January 22nd, 2013|Legal News|1 Comment

Hernia Mesh Complications- Is the FDA Watching? Part II

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 Read more

By | 2012-11-28T21:33:28+00:00 November 28th, 2012|Hernia Mesh Injuries, Medical News|33 Comments

Dollars and Sense? Saving Money on Hernia Mesh

  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 Read more

By | 2012-09-17T23:38:29+00:00 September 17th, 2012|Featured, Hernia Mesh Injuries|1 Comment
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