FOLDALITE III 32 LAMP

Additional Manufacturer Narrative

NATIONAL BIOLOGICAL INVESTIGATED THE INCIDENT AND FOUND THE FOLLOWING INFORMATION. WHILE IT IS THE PHYSICIAN'S CHOICE ON THE PATIENT'S TREATMENT DOSAGES, IT WAS FOUND THAT THE PATIENT DOSAGE WAS MORE THAN DOUBLE OF THE RECOMMENDED DOSAGE LISTED IN THE IFU. THE SHELK & MORGAN PROTOCOL, REFERENCED IN OUR IFU, RECOMMENDS A SKIN TYPE OF I TO BE TREATED AT 520 MJ/CM2 AS A GOAL DOSAGE. THE PATIENT (HAS A SKIN TYPE OF I) WAS BEING TREATED AT 1375 MJ/CM2. STANDARD PROTOCOL ALSO RECOMMENDS A DOSAGE DECREASE OF AS MUCH OF 50% ONCE ERYTHEMA OCCURS, THIS DID NOT OCCUR IN THIS INSTANCE.

Description of Event or Problem

PATIENT EXPERIENCED OVERTREATMENT AT A CLINIC. THE PATIENT RECEIVED PHOTOTHERAPY TREATMENTS FOR > 1 YEAR AT THIS CLINIC. THE PATIENT BLISTERED AFTER ONE OF THEIR TREATMENTS AND WAS TREATED WITH PRESCRIPTION STRENGTH HYDROCORTISONE. THE TREATMENT WAS MORE THAN DOUBLE THE DOSE RECOMMENDED IN THE OPERATIONS MANUAL.