MAUDE Reports are Fraud Reports: FDA & Johnson & Johnson’s Acclarent Relieva Spin Sinuplasty System

MAUDE Reports are Fraud Reports: FDA & Johnson & Johnson’s Acclarent Relieva Spin Sinuplasty System

February 18, 2016

ACCLARENT, INC. RELIEVA SPIN SINUPLASTY SYSTEM INSTRUMENT, ENT MANUAL SURGICAL Back to Search Results

Model Number N/A Device Problem No Known Device Problem Event Date 12/12/2015 Event Type  Injury Event Description Acclarent was informed of an event on (b)(6) 2016, which occurred on (b)(6) 2015, during a balloon sinuplasty in-office (bspio) procedure in which the patient experienced an adverse reaction. During the procedure the patient was administered 30 mg of liquid versed (midazolam). Later in the procedure the patient was reported to have struggled to remain conscious. The physician was able to successfully dilated both frontal sinuses and right maxillary sinus. The patient was bleeding heavily from the nose and appeared to have soiled himself and aspirated on his vomit. The physician attempted to clear the patient’s airway with a yankauer suction and attempted to administer oxygen to the patient. Emergency medical service (ems) was dispatched by 911 service. The patient was reported to have low oxygen saturation (~80%) but was stable and semi-conscious. The patient was transported via ambulance to the hospital. There was no reported malfunction with any of the acclarent products used during the case. Thus, this event is unrelated to the devices and most likely related to the procedure or patient’s pre-existing condition. The patient’s current condition is not known.

FDA MAUDE report database: The Sociopathic Business Model™, states that companies (and the government is a company as is Johnson & Johnson’s Ethicon’s Acclarent) place blame without shame, remorse, guilt or accountability at the expense of employees, patients, consumers & taxpayers.

Manipulation of facts:

Device Problem: No Known Device Problem

Johnson & Johnson’s Ethicon’s Acclarent and FDA will be quick to blame the rep, the surgeon, and even the patient; and they’ll use No Known Device Problem to clear their collective conscious.  The problem is, executives at Johnson & Johnson, Ethicon, Acclarent decided to increase sales from just the operating room & surgery center (where qualified staff like anesthesiologists are required) to expanding their market to include in-office (where employees are not required to know how  to administer anesthesia or deal with a patient crashing, like a hospital or surgery center).   Johnson & Johnson’s  Ethicon’s Acclarent’s decision was not based on surgeon request or patient request or need, it was an economic decision of putting profit before patients by (among others) those at the center of a current criminal federal investigation, former Johnson & Johnson Ethicon Acclarent CEO William (Bill) Facteau (currently EarLens CEO) and VP of Sales & Training Patrick (Pat) Fabian (currently NxThera COO), on an unrelated product, which demonstrates this pattern of unethical and or illegal activity that’s encouraged, replicated and rewarded.

• patient was reported to have struggled to remain conscious
• patient was bleeding heavily from the nose and appeared to have soiled himself and aspirated on his vomit
• emergency medical service (ems) was dispatched by 911 service
• patient was transported via ambulance to the hospital

*if this were done in the hospital, as was the original intent of the balloon sinuplasty devices, the patient’s saftey wouldn’t have been compromised nor would the patient/doctor have incurred additional emerengy fees.

That information is missing from the MAUDE report on the FDA database  as is the fact that these devices were approved for surgery and now being used improperly in an environment in which they were not designed. This MAUDE report will likely be removed from the database in the near future because the device was not found at fault, but the device should never have been allowed to used in-office.   FDA approves the device and pays no attention to where it’s being used, hiding behind plausible deniability, but it’s their job to know when, where and how the devices they approved are used.  Did it even trigger a red flag at FDA that a surgical device was being used in-office? 

Thus, this event is unrelated to the devices and most likely related to the procedure or patient’s pre-existing condition

Nope, not even close, Johnson & Johnson’s Ethicon’s Acclarent and FDA (via posting this MAUDE report) don’t get to blame the surgeon, and certainly not the patient while not taking accountability.

Employees are pressured not to fill out MAUDE reports (or to place blame when they do) from managers who threaten retaliation who fear executives who created a plan based on greed and not on patient need.  Doctors trust their reps, patients trust their doctors and the companies and FDA just keep placing blame without taking accountability.  I personally know this cycle all too well, as a former Johnson & Johnson, Ethicon, Acclarent employee who was wrongfully terminated for trying to expose the problems within the company ranging from sexism, retaliation, and manipulated into selling a product off-label.

Innovation is used as a manipulation to allow for companies to put profit before patients. Not until employees come forward (thank you to the likely rep that posted MAUDE report on Medtech[y]) and doctors sue the companies with the patients can we hope to create positive change in the industry, including reform at FDA.