MAUDE Adverse Event Report: HEALTHLIGHT LLC. BRAINTAP BLUETOOTH HEADSET; LAMP, INFRARED, THERAPEUTIC HEATING

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

Patient Problem Convulsion/Seizure (4406)

Event Date 05/31/2021

Event Type  Injury  

Event Description

The date of the occurrence is not known for sure.By hearsay, i found out that the product caused a seizure in a child.The device can induce seizures by blinking a blue led within an inch of the end user's face.No black label, no warnings.Search "braintap headset" to see the product.Braintap (headquartered in new bern n.C.) is registered as excel management group in delaware.

• Brand Name: BRAINTAP BLUETOOTH HEADSET
• Type of Device: LAMP, INFRARED, THERAPEUTIC HEATING
• Manufacturer (Section D): HEALTHLIGHT LLC.
• MDR Report Key: 16584136
• MDR Text Key: 311796469
• Report Number: MW5115879
• Device Sequence Number: 1
• Product Code: ILY
• 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: 03/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other