HANDISOL II

Description of Event or Problem

PATIENT'S PHYSICIAN REPORTED TO NATIONAL BIOLOGICAL THAT THE PATIENT EXPERIENCED BLISTERING BURNS ON THE PATIENT'S HANDS AND ARMS AFTER THE INITIAL TREATMENT WITH THE HANDISOL II HOME PHOTOTHERAPY UNIT. PATIENT VISITED EMERGENCY ROOM THE DAY AFTER THE INITIAL TREATMENT WHERE SHE RECEIVED TREATMENT: BLISTERS WERE POPPED, MEDICATED BURN OINTMENT WAS APPLIED AND THEN AQUAFILL WAS USED ON THE BURNS BEFORE WRAPPING THEM. THE PATIENT HAS SUBSEQUENTLY BEEN TO SEE THE DOCTOR WHO HAS CHANGED HER TREATMENT TO THE USE OF BETACELL CREAM, AND THEM WRAP IN A VINEGAR WRAP. THIS TREATMENT IS TO BE FOLLOWED FOR AT LEAST 2 WEEKS UNTIL THE PATIENT HEALS. THE PATIENT HAD NOT HAD ANY PRIOR USE OF UV LIGHT TO TREAT PSORIASIS. THE PATIENT WAS DIRECTED BY THE PHYSICIAN TO USE THE TREATMENT PLAN IN THE BOOKLET WHICH COMES WITH THE MACHINE. THE PATIENT DID NOT FOLLOW THE INSTRUCTIONS IN THE OPERATIONS MANUAL. PATIENT DID NOT FOLLOW WARNINGS AND CAUTIONS STATED IN THE UNIT'S OPERATIONS MANUAL. THE PATIENT DID NOT KNOW HER SKIN TYPE. THE SKIN TYPE IS WHAT ALLOWS THE PATIENT TO KNOW THE CORRECT TREATMENT PROTOCOL. THE PATIENT USED THE UNIT FOR THE MAXIMUM AMOUNT OF TIME OF 10 MINUTES INSTEAD OF THE AMOUNT OF TIME DIRECTED IN THE TREATMENT PROTOCOL.