InjuryILY

BRAINTAP BLUETOOTH HEADSET

Received Mar 20, 2023 · Event occurred May 31, 2021

Report MW5115879 · MDR key 16584136

Device

Generic name

Lamp, Infrared, Therapeutic Heating

Manufacturer

Healthlight Llc.

Product problems

Adverse Event Without Identified Device or Use Problem

Patient

Unknown

Convulsion/Seizure
Convulsion/Seizure

Narrative

Description of Event or Problem

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.