MAUDE Adverse Event Report: AKILIINTERACTIVE LABS, INC. ENDEAVOROTC; DIGITAL THERAPEUTIC SOFTWARE FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER

Patient Problem Nausea (1970)

Event Type  malfunction  

Event Description

The "fda approved" adhd game endeavorotc is predatory in nature.Nothing their game requires a person to do is any different from any other video game, yet they're charging a monthly subscription that way outpaces the cost of even the best aaa games.There is no ongoing production cost as there would be for regular meds, so charging such high costs is unnecessary and predatory.The worst part is they are targeting the group most known for forgetting to cancel a subscription (adhd) and not offering a free alternative.You are required to sign up to even try the product.They are intentionally targeting a vulnerable population with false claims and false hope.There are also reports of prohibitive nausea, which isn't included as any sort of side effect warning.This product should not be approved by the fda.At the least, it should carry a warning for nausea and be required to disclose its exorbitant fee upfront.Thank you for your time.

• Brand Name: ENDEAVOROTC
• Type of Device: DIGITAL THERAPEUTIC SOFTWARE FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER
• Manufacturer (Section D): AKILIINTERACTIVE LABS, INC.
• MDR Report Key: 17799340
• MDR Text Key: 324143508
• Report Number: MW5146040
• Device Sequence Number: 1
• Product Code: QFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/19/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2023
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White