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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Wasn't effective.

• Brand Name: ENDEAVORRX
• Type of Device: DIGITAL THERAPEUTIC SOFTWARE FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER
• Manufacturer (Section D): AKILIINTERACTIVE LABS, INC.
• MDR Report Key: 18058641
• MDR Text Key: 327371480
• Report Number: MW5147655
• Device Sequence Number: 1
• Product Code: QFT
• 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: 10/26/2023

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: 11/01/2023
• Patient Sequence Number: 1
• Patient Sex: Male