Description of Event or Problem · 0
(B)(6) IS A 26 YO WOMAN WHO SUFFERED FROM MENTAL HEALTH PROBLEMS AND SUBSTANCE USE DISORDER. UNDER THE CARE OF (B)(6) IS (B)(6) , AURA LLC¿S UNAPPROVED MEDICAL DEVICE WAS USED ON HER. A VIDEO FROM AURA LLCS CEO PROVES THIS¿SHE DISSEMINATED THE VIDEO AS MARKETING. (B)(6) DIED LESS THAN A MONTH AFTER RECEIVING TREATMENT. I ALLEGE THIS IS A WRONGFUL DEATH CAUSED BY THE UN-AUTHORIZED, EXPERIMENTAL TREATMENT SHE RECEIVED. ANY INVESTIGATION INTO AURA LLC WILL SHOW THEY¿RE IGNORANT OF ALL OF THE INDUSTRIES REGULATORY REQUIREMENTS. THEY HAVE NO CLINICIANS ON STAFF, NO SCIENTIFIC ADVISORY BOARD, NO QMS, NO INITIATION OF CLINICAL TRIALS, NO FDA EXEMPTION OR APPROVAL LETTERS, AND ARE EXPERIMENTALLY TESTING THEIR UNAPPROVED MEDICAL DEVICE IN NON-AUTONOMOUS PATIENT POPULATIONS, VIOLATING MEDICAL ETHICS, FOR PECUNIARY SELF-ENRICHMENT. THEY¿RE UNAWARE OF 21 CFR OR THE FDA GUIDELINES ENTIRELY. THEY¿RE ALSO FALSELY ADVERTISING TO TREAT NINE (9) INDICATIONS WITH THEIR MEDICAL DEVICE ON THEIR COMPANIES WEBSITE ((B)(6)). YOU HAVE A STUPIDER (B)(6) ON YOUR HANDS.