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#CrimingWhileWhite :Patient Death: Johnson & Johnson’s Ethicon’s Acclarent

#CrimingWhileWhite :Patient Death: Johnson & Johnson’s Ethicon’s Acclarent

December 3, 2014

Are MAUDE Reports FRAUD Reports?

The-Sociopathic-Business-Model™ EEOC to Case Study  Encouraged, Replicated and Rewarded

25 MAUDE Adverse Event Reports from the fda.gov site

Device Malfunction

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.

MAUDE Report Acclarent Balloon Sinuplasty Rupture

CSF Leak

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.

Acclarent MAUDE Report

 Original Source: Medtech[y]

Now Missing from the FDA MAUDE site

PATIENT DEATH

Acclarent Balloon Sinuplasty Death

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.

Medtechy Acclarent coaching to cut costs to help pay for the balloon

Example of how the company “coaches” reps to work around the high cost of their product putting profits before patients

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.

#CrimingWhileWhite JNJ CEO Alex Gorsky

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

2 Comments
  • Thank you for the insider insights. I remember when Wendell B. Potter provided his whistleblower testimony to the Senate in 2009 and his interview with Bill Moyers/PBS and Sanjay Gupta/CNN. Because he was a former CIGNA insurance Communications Director he was listened to even though there were millions of uninsured Americans that should have been given the microphone much earlier. It takes courage to stand up for truth and honesty. I hope you will read my blog and consider us allies in this disruption of our stagnant and cruel medical culture.

    December 4, 2014 at 4:09 pm

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