#CrimingWhileWhite :Patient Death: Johnson & Johnson’s Ethicon’s Acclarent
December 3, 2014
25 MAUDE Adverse Event Reports from the fda.gov site
Whoops! A balloon missing is a pretty big deal and to be missing from the initial report? Why else would there be a report? That’s inconsistent & contradictory langauge to action.
A CSF leak is a cerebrospinal fluid leak or when the fluid from around the brain and spine leak which is a big deal. If not treated properly it could cause meningitis or brain swelling.
Now Missing from the FDA MAUDE site
The FDA cannot (or at least should not legally be able to arbitrarily) take down MAUDE reports but rather should be legally bound to add notes regarding decisions that change the facts of a report. It’s implied that the patient was risk 3 anesthesia or heavy risk to life but it’s not indicated if an autopsy was performed which allows the device maker off the hook without any accountability. When events like this where a patient’s heart stops devices often get tossed in the panic and as the report says “No Known Device Problem,” and true to form was “discarded and not available for eval.” Based on that inconclusive information this report should remain on the government MAUDE website database.
Unethical & illegal behavior is encouraged, replicated and rewarded. Accountability should likely be shared on all parts with the surgeon who made the decision to operate under conscious sedation of a risk 3 patient for an elective procedure (non-life threatening) and it would be interesting to know if the surgeon owned part of the surgery center and Johnson & Johnson’s Ethicon’s Acclarent for creating a business model that put profits before patients and creating an environment that rewards unethical and illegal activity and the DOJ for allowing another death to happen without any forced accountability for the company.
We the people should not allow two corrupt entities, the device makers and the U.S. Government, to make any decisions regarding our health behind closed doors. Especially Johnson & Johnson who’s been forced to pay well over $5 billion in federal fines over the last three years with even more pending with hips and mesh cases is nothing short of a serial killer with the government’s blessings. Boycott Johnson & Johnson