MAUDE Adverse Event Report: AURA LLC ON-SITE VIRTUAL REALITY SYSTEM PRECISION TREATMENT; DEVICE, BIOFEEDBACK

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Event Description

(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.

• Brand Name: ON-SITE VIRTUAL REALITY SYSTEM PRECISION TREATMENT
• Type of Device: DEVICE, BIOFEEDBACK
• Manufacturer (Section D): AURA LLC
• MDR Report Key: 16103166
• MDR Text Key: 306794238
• Report Number: MW5114164
• Device Sequence Number: 1
• Product Code: HCC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 26 YR
• Patient Sex: Female