MAUDE Adverse Event Report: NEUROFIELD, INC. Q-CHECK; DEVICE, BIOFEEDBACK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Sleep Dysfunction (2517)

Event Date 11/11/2022

Event Type  Injury  

Event Description

My son was doing neurofeedback at the (b)(6) in (b)(6) under (b)(6), lcpc using a neurofield device.He developed a side effect of falling asleep suddenly every 1 to 4 minutes on friday (b)(6) 2022.He has fallen asleep and fallen down while he is walking, talking, eating, swallowing, and playing basketball and in many other scenarios.He will fall asleep, and his body will fall limp to the floor.The (b)(6) told us that "you can't hurt anyone using neurofeedback" and that his symptoms would go away within a few days.We are very concerned that his symptoms have not resolved, and he cannot stay awake.He is falling down and getting hurt.We requested that they contact the makers of the device for guidance, and they refused.We requested that they reach out to medical professionals for assistance, and they refused.(the (b)(6) has a doctor who supposedly oversees the neurofeedback, but we were not put in touch with her when this happened).We took our son to our own medical doctor today and he is referring us to a pediatric neurologist.We are taking our son for an eeg at the hospital tomorrow morning.We are concerned that this device has permanently damaged and disabled our son by causing him a serious medical disorder.We feel that the neurofield device and neurofeedback should not continue and there is not support by medical providers who take this field seriously and understand the harm they can do and act responsibly.Please remove this device so that others are not harmed permanently.Fda safety report id# (b)(4).

• Brand Name: Q-CHECK
• Type of Device: DEVICE, BIOFEEDBACK
• Manufacturer (Section D): NEUROFIELD, INC.
• MDR Report Key: 15844092
• MDR Text Key: 304308914
• Report Number: MW5113414
• Device Sequence Number: 1
• Product Code: HCC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ALLEGRA; ARNUITY; B-COMPLEX ; MAGNESIUM; SPIRIVA
• Patient Outcome(s): Other; Required Intervention; Life Threatening; Disability
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White