Are FDA MAUDE Reports a Fraud? A Case Study
Directly from the FDA MAUDE Google Search May 5, 2014
Updated 5/27/2014 (Stratus has not been on the US market since May 15, 2013)
And yet it’s available today on ebay???? Things that make you go hmmmmm
MAUDE data mandatory from the FDA represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.191.
How can a MAUDE Report be both mandatory and voluntary?
Can MAUDE reports be edited by the Manufacturer? Can the FDA indiscriminately take down MAUDE reports? These reports, though not by design, have helped patients recognize problems with manufacturer’s devices and in turn put pressure on the FDA to make changes, like in the mesh trials. It should concern all when there are such inconsistent and contradictory actions and langue on their own site, that’s set to protect us.
We’ll use Johnson & Johnson’s Ethicon’s Acclarent’s Stratus Microflow Spacer (Ethmoid and Frontal) and Adverse Events with the two products to demonstrate a point. The point is: math is either hard for the FDA or MAUDE Reports can come and go, but who gets to decide?
And today just minutes apart on the FDA MAUDE website:
AND MOMENTS LATER….
Same product went from 5 Adverse Events to 2 in a matter of seconds on the site; and then there’s this screenshot from 2012 that clearly shows 10 Adverse Events. Even if the both products and their Adverse Events were added together….it still does not add up.