Description of Event or Problem · 0
THE COMPLAINANT REPORTED PURCHASED A MEDICAL DEVICE (HELMET) NAME THERADOME WEARABLE LASER PHOTOTHERAPY TECHNOLOGY (LPT) DEVICE ONLINE AT WWW.THERADOME.COM IN (B)(6) 2023 FOR HAIR GROWTH. SHE STATED HAS BEEN USING THE DEVICE FROM (B)(6) 2023 BUT STOPPED USING IT IN (B)(6) 2024 WHEN SHE UNPLUGGED IT, THE CHARGER BROKE. THE COMPLAINANT ALSO STATED THERE ARE SOFTWARE ISSUES, WHEN YOU PLACE THE "HELMET" ON YOUR HEAD TO START THE TREATMENT, YOU HEAR A VOICE COUNT-DOWN FROM 20 MINS, THE COUNTDOWN STOPS AT THE 5-MINUTE COUNT, DOES NOT SHUT OFF. SHE STATED THE DEVICE COMES WITH FOAM PADS INSIDE THE HELMET DOESN'T STAY ON, SLIPS ALL OVER THE HEAD. NO ILLNESS REPORTED. SHE STATED, WANTS TO CONTINUE USING THE DEVICE BUT WANTS A REPLACEMENT DEVICE FROM THE COMPANY. SHE REPORTED THIS ISSUE TO THE COMPANY, THEY RESPONDED WILL SEND CONSUMER A REPLACEMENT DEVICE, BUT SHE WOULD NEED TO RETURN THE ORIGINAL ONE; THE COMPLAINANT STATED DOES NOT WANT TO RETURN THE ORIGINAL PRODUCT, WANTS TO KEEP BOTH THE ORIGINAL AND WANTS A NEW ONE FROM THE COMPANY. SHE STATED WANTS TO KEEP THE ORIGINAL DEVICE AND WANTS A BRAND NEW ONE ALONG WITH A 5-YEAR WARRANTY AT NO COST TO HER. THE COMPLAINANT STATED WANTS FDA TO ASSIST HER IN GETTING THE COMPANY TO SEND HER A NEW DEVICE AND 5-YR WARRANTY FOR FREE. I EXPLAINED FDA IS A REGULATORY AGENCY, FDA DOES NOT GET INVOLVED WITH MONETARY ISSUES.