PANOSOL 3D

Description of Event or Problem

PATIENT REPORTED TO HAVE 2ND DEGREE BURNS AFTER TREATMENT WITH UV PHOTOTHERPY EQUIPMENT. PATIENT HAD PREVIOUS TREATMENT HISTORY AT DERMATOLOGIST'S OFFICE USING A CLINICAL PHOTOTHERAPY UNIT. A HOME UNIT WAS PRESCRIBED TO HER AS SHE NO LONGER WANTED TO GO TO THE OFFICE FOR TREAMENT DUE TO COVID CONCERNS. SHE SUSTAINED THE BURNS UPON HER FIRST USAGE OF THE EQUIPMENT. ALTTHOUGH SHE SAID SHE HAD READ THE OPERATIONS MANUAL, SHE USED A 4 MINUTE EXPOSURE TIME ON BOTH THE FRONT AND BACK SIDES OF HER BODY. THE RECOMMENDED FIRST USAGE TREATMENT TIME PER THE OPERATIONS MANUAL FOR A PERSON WITH HER SKIN TYPE (TYPE II) WAS 1 MIN 13 SEC. SHE HAD DECIDED TO USE THE SAME TIME SHE HAD BEEN USING AT THE DERMATOLOGIST'S OFFICE (5 MINUTES) MINUS 1 MINUTE EVEN THOUGH THERE IS NO CORRELATION REGARDING TREATMENT TIMES BETWEEN CLINICAL AND HOME UNITS. THE PATIENT MISINTERPRETED THE MANUAL THAT STATED THAT THE PREVIOUS EXPOSURE TIME SHOULD BE USED IF TREATMENT WAS INTERRUPTED FOR 8-11 DAYS. THIS WAS NOT INTENDED TO MEAN THAT THE PREVIOUS TIME USING A NON-LIKE UNIT SHOULD BE USED. THE PATIENT PROVIDED PHOTOS OF HER BURNS TO HER DERMATOLOGIST AND WAS PRESCRIBED ANTIBIOTICS, STEROIDS AND A TOPICAL CREAM FOR TREATMENT.

Additional Manufacturer Narrative

PATIENT WANTED TO KEEP DEVICE, THEREFORE IT WAS NEVER SENT BACK TO MANUFACTURER FOR EVALUATION.