PHOTHERA P600

Description of Event or Problem

I AM A PATIENT WITH MULTIPLE SCLEROSIS REPORTING AN ADVERSE EVENT AND SUSPECTED DEVICE MALFUNCTION INVOLVING A PHOTHERA P600 HOME PHOTOTHERAPY DEVICE TO TREAT ECZEMA THE PRESCRIBER, (B)(6), CNP AT (B)(6) IN (B)(6), DENIED MY REQUEST FOR AN ALTERNATE VENDOR, INSISTING ON THE SAFETY AND RELIABILITY OF PHOTHERA FOR HOME UV PHOTOTHERAPY. WITHIN WEEKS OF BEGINNING THERAPY, I EXPERIENCED REPEATED SUNBURNS DESPITE FOLLOWING INSTRUCTIONS: STANDING AT LEAST 9 INCHES FROM THE UNIT, WEARING SUNBLOCK ON MY FACE (LATER EXTENDED TO CHEST/NECK AT MY CLINICIAN'S SUGGESTION), AND USING THE SAME CLOTHING (CHEMISE) TO KEEP EXPOSURE CONSISTENT. I REPORTED THESE SUNBURNS TO MY PRESCRIBER VIA THE TRIHEALTH MYCHART SYSTEM ON (B)(6) AND AGAIN ON (B)(6), INCLUDING PHOTOS OF BURNS MY PRESCRIBER ADVISED CONTINUED USE WITH SUNSCREEN AND CLOTHING ADJUSTMENTS, AND INDICATED THAT DOSE CHANGES HAD TO BE ARRANGED THROUGH PHOTHERA. I THEN CONTACTED PHOTHERA VIA THEIR CUSTOMER SERVICE TICKETING SYSTEM ON (B)(6), REPORTING SEVERE SUNBURNS AND THAT THE DEVICE WAS "WAY TOO POWERFUL" FOR MY FAIR SKIN. I HEARD NOTHING IN REPLY. I LEARNED BY SEARCHING MY PATIENT RECORD THAT MY CLINIC CONTACTED PHOTHERA ON (B)(6) AND WAS TOLD THAT, DESPITE THE PRESCRIPTION INDICATING SKIN TYPE I/II AND A TARGET OF 200¿250 MJ, MY DEVICE HAD BEEN SET TO A PROTOCOL FOR SKIN TYPE III, WITH A RESULTING DOSE OF APPROXIMATELY 400 MJ. PHOTHERA ALLEGEDLY AGREED TO ADJUST MY DEVICE TO 200 MJ AND SEND A "FIXER USB," BUT I NEVER HEARD OF THIS ARRANGEMENT, AND NEVER RECEIVED A USB. OVER THE FOLLOWING WEEKS, I CONTINUED TO REPORT UNPREDICTABLE BURNS TO MY PRESCRIBER AND SEPARATELY TO PHOTHERA, BY PHONE, ONLINE CHAT, AND EMAIL. RESPONSES FROM THE COMPANY WERE DELAYED AND FRAGMENTED. MEANWHILE, I CONTINUED TO USE THE DEVICE AS PRESCRIBED, BUT EXPERIENCED INTERMITTENT BURNS AND MARKED HEAT EXPOSURE. MY ECZEMA RESOLVED BUT MY ANXIETY MOUNTED BECAUSE I FELT UNSAFE AND UNHEARD. ON MARCH 9, 2026, A PHOTHERA REPRESENTATIVE NAMED (B)(4) CALLED ME MID TREATMENT. THE CONTROL INTERFACE ON MY UNIT DID NOT MATCH HER EXPECTATIONS OR THE DESCRIPTION IN THE COMPANY'S WEBSITE OR EMAIL. I ASKED HER IF I COULD SEND A PHOTO OF MY SCREEN. SHE WAS ALARMED TO SEE I WAS RECEIVING A DOSE OF 5321 MJ. SHE STATED THAT 5321 MJ IS A "VERY HIGH" VALUE AND THAT SHE HAD "NEVER SEEN IT GET THAT HIGH." SHE INSTRUCTED ME TO USE THE ARROWS TO REDUCE THE DOSE TO THE LOWEST SETTING, 200 MJ. MY PRESCRIBER HAD LED ME TO BELIEVE THAT I COULD NOT ADJUST THE DOSE MYSELF. AS A HIGHLY MYOPIC PATIENT WHO MUST WEAR THE DEVICE-SPECIFIC GOGGLES DURING TREATMENT, I HAD NEVER BEEN ABLE TO READ THE SMALL CHARACTERS ON THE SCREEN. THIS WAS MY FIRST TIME LEARNING THAT THE NUMBERS ON THE DISPLAY REPRESENTED THE TREATMENT DOSE IN MILLIJOULES (MJ) AND THAT THE SQUIGGLES REPRESENTED ARROWS. WHEN I FOLLOWED (B)(6)'S INSTRUCTIONS, I DISCOVERED THAT I COULD ONLY REDUCE THE DOSE DOWN TO 400 MJ, NOT 200 MJ. SHE ASKED ME TO CONTINUE MY DAY'S TREATMENT 400 MJ BUT BY THIS POINT MY MS SYMPTOMS OF PAIN AND FATIGUE HAD ALREADY BEEN TRIGGERED BY THE INTERRUPTED TREATMENT AT 5321 MJ. I HAVE SINCE DECIDED TO DISCONTINUE USE BECAUSE I NO LONGER FEEL SAFE. MOREOVER, I AM CONCERNED THAT OTHERS USING THIS DEVICE MAY BE UNSAFE AS WELL. ON -3/12/26 I CONTACTED PHOTHERA TO REQUEST THEY SEND ME A FLASH DRIVE SO I CAN LEARN THE FULL EXTENT OF THE DAMAGE. THEY AGREED TO HAVE THEIR ENGINEERS ANALYZE MY USAGE DATA AND SEND THAT ANALYSIS TO MY CLINICIANS. I CONTINUE TO EXPERIENCE EXACERBATION OF MY MULTIPLE SCLEROSIS SYMPTOMS, AS WELL AS SLEEPLESSNESS, FATIGUE AND ANXIETY ABOUT OVERDOSING, ESPECIALLY IN VULNERABLE PATIENTS USING DEVICES UNSUPERVISED AT HOME.