MAUDE Adverse Event Report: AUTONOMOUS USER REHABILITATION AGENT; COMPUTERIZED BEHAVIORAL THERAPY DEVICE FOR PSYCHIATRIC DISORDERS

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	05/09/2021
Type of Reportable Event	Death
Event or Problem Description
A tech startup called autonomous user rehabilitation agent (aura) is marketing experimental virtual reality applications and tools to psychiatric care facilities, local governments, and rehabilitation hospitals.The problem is that one user of this tech is already dead, and we have discovered that (b)(6) lied publicly about the victim's cause of death as well as the drugs in the victim's system at the time of death.Aura's ceo, (b)(6) (going by several pseudonyms), has appeared publicly on interviews and youtube videos touting the product as "evidence based", but points to no medical tests or studies.However, as recently as (b)(6) 2021, aura's "program director", (b)(6)., admitted publicly that the company is still running "case studies" to prove the technology's "efficacy".(b)(6), the ceo, publicly conspired with a famous youtuber to put a homeless, crack-addicted woman named (b)(6) into court ordered treatment in (b)(6) county.(b)(6) quickly relocated (b)(6) to a facility in (b)(6) where she was used as a test subject for the experimental virtual reality technology.(b)(6) approach, which she calls "virtual reality exposure therapy", depends on intentionally "triggering" strong emotional responses in addicts and mental patients in order to "help with their healing".The problem is (b)(6) is using this technology on people she puts in treatment against their will.(b)(6) was a homeless woman living on skid row.(b)(6) publicly conspired to force (b)(6) into court ordered treatment, relocated (b)(6) to a different state, and used this experimental technology on (b)(6) under the threat of going to prison for 3-5 years.(b)(6) ultimately died from cardiac arrhythmia, but (b)(6) appeared on a youtube video stating (b)(6) cause of death was "seizure disorder".(b)(6) also stated that (b)(6) did not have anything in her system but tylenol.I have obtained the autopsy report and that is also false.(b)(6) had many pharmaceutical medications in her system at the time, including 3 for high blood pressure and one for seizures.I am afraid that (b)(6) is using this technology on other vulnerable people against their will who will meet the same fate as (b)(6).(b)(6) has also petitioned to put mtv reality star, (b)(6), in a conservatorship in (b)(6) and i have reason to believe she is using this technology on him as well.Fda safety report id# (b)(4).

• Brand Name: AUTONOMOUS USER REHABILITATION AGENT
• Common Device Name: COMPUTERIZED BEHAVIORAL THERAPY DEVICE FOR PSYCHIATRIC DISORDERS
• MDR Report Key: 14117437
• Report Number: MW5108993
• Device Sequence Number: 18173667
• Product Code: PWE
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American