PANOSOL 3D

Description of Event or Problem

PATIENT CALLED NATIONAL BIOLOGICAL CUSTOMER SERVICE FOR ADVICE ON EXPOSURE TIME FOR HER FIRST TIME USE OF NB-UVB PHOTOTHERAPY DEVICE. PATIENT HAD BEEN DIAGNOSED WITH MYCOSIS FUNGOIDES AND HER DOCTOR HAD NOT GIVEN ANY INSTRUCTION OF APPROPRIATE DOSAGE. DOCTOR WAS NOT AVAILABLE SO PATIENT REQUESTED ASSISTANCE FROM NATIONAL BIOLOGICAL. PATIENT HAD A KNOWN SKIN TYPE II BUT OPERATIONS MANUAL DOES NOT INCLUDE A PROTOCOL FOR HER DISEASE. OPERATIONS MANUAL LISTS AN INITIAL EXPOSURE TIME OF 1 MINUTE 13 SECONDS FOR A SKIN TYPE II PSORIASIS PATIENT AND WAS GIVEN THAT VALUE AS A RECOMMENDATION. PATIENT TREATED AT THAT TIME INTERVAL FOR BOTH FRONT AND BACK. SIX HOURS LATER SHE WAS EXPERIENCING SEVERE ERYTHEMA WITH PAIN AND REDDENING OF MOST OF HER EXPOSED AREAS. SHE CALLED DOCTOR AND WAS PRESCRIBED SILVER SULFADIAZINE FOR TREATMENT OF HER BURNS. SHE THEN REPORTED THE INCIDENT TO NATIONAL BIOLOGICAL VIA COMPANY EMAIL. PATIENT WAS INTERVIEWED ON (B)(6) 2024 AND WAS IN PEELING STAGE OF BURN BUT OTHERWISE IN ACCEPTABLE CONDITION. PATIENT CONSULTED HER PHYSICIAN AND IT WAS CONCLUDED THAT HER INITIAL EXPOSURE HAD BEEN TOO GREAT THEREBY CAUSING THE BURNS. SHE MAY HAVE HAD HEIGHTENED SENSITIVITY TO PHOTOTHERAPY DUE TO HER CONDITION, BUT IT IS UNKNOWN AS TO WHETHER THAT WAS A CONTRIBUTING FACTOR. THE PATIENT HAS DECIDED TO RETAIN HER EQUIPMENT AS THERE WAS NO EVIDENCE OF MALFUNCTION. AFTER HEALING, SHE WILL ATTEMPT TO USE THE EQUIPMENT AGAIN AT A SUBSTANTIALLY REDUCED EXPOSURE TIME. STUDIES HAVE SHOWN THAT PHOTOTHERAPY CAN BE EFFECTIVE FOR PATIENTS WITH HER AILMENT AND PREVIOUS USE OF PHOTOTHERAPY 6 YEARS PREVIOUS HAD BEEN EFFECTIVE FOR HER.