York, PA – “A good number of attorneys have reported transvaginal mesh adverse events to the FDA on behalf of their clients/patients, but over 23,000 reports are from physicians,” says Madris Tomes, founder of Device Events and former FDA Program Manager. “Physicians are not great at reporting— this is a HUGE number.”
Device Events LLC Launches Medical Device Adverse Event Reporting Service
York, PA USA — 3 January 2017 – Device Events, LLC announced today the commercial launch and availability of their cloud-based medical device recall and adverse event search, reporting, and analysis service.
Device Events LLC, founded by Ms. Madris Tomes in 2015, provides a cloud-based software service that extracts, consolidates and provides easy access to clear and comprehensive information on the millions of medical device adverse event reports (MDRs) filed with the FDA.
CNN Reports – FDA spotlights unapproved use of drugs, medical devices // Madris Tomes – Speaks at FDA Public Hearings
(CNN) Many rules regulate the way pharmaceutical companies tell you, doctors and insurance companies about their products.
Drug and medical device makers, insurance companies, lawyers and patients packed a room for two full days of public hearings at the Food and Drug Administration’s campus in Silver Spring, Maryland, this week to debate those rules.
FDA Spoke and Power Morcellator Use Dropped
Or was it the fear of lawsuits that curtailed use of the laparoscopic surgical devices?
Qmed recently looked to Device Events for thoughts on JAMA study on morcellators. Here’s a link to the recent article.
Device Events featured on CNBC Power Lunch
Learn about how potentially mis-classified adverse events could be understating the risk of medical devices.
Maetrics UDI White Paper
CMS’ pushback on integrating UDI into claims payment systems may now be a thing of the past. Learn how early compliance and understanding the intent of the UDI rule will help smooth the way for UDI in EHRs and in Claims.
The PDF link below can be viewed in your browser and is downloadable.
https://www.deviceevents.com/wp-content/uploads/2016/06/Maetrics-UDI-White-Paper.pdf
FDA mandates new warnings, new data for Essure contraceptive device
Updated 10:01 AM ET, Tue March 1, 2016
(CNN)The U.S. Food and Drug Administration said it will require a new “black box warning” label for Essure, an implantable permanent contraceptive device. A black box warning in the labeling of products is “designed to call attention to serious or life-threatening risks,” according to the FDA website.
Monday’s announcement comes after more than 5,000 women filed grievances with the FDA between November 2002 and May 2015, complaining of unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding after an Essure implantation.
Click here to read more: http://www.cnn.com/2016/02/29/health/fda-essure-birth-control-device/index.html
Congressman, Consultant Discuss Goals in Raising Claims About Essure | RAPS https://t.co/HpHGzniZJn via @sharethis
— Madris Tomes (@DeviceEvents) February 23, 2016