PANOSOL 3D

Additional Manufacturer Narrative

THIS INCIDENT WAS RECEIVED ON 08/05/2020. THIS REPORT IS BEING SUBMITTED AUGUST 2021. THIS REPORT WAS NOT INITIALLY SUBMITTED SINCE NATIONAL BIOLOGICAL CORP BELIEVED THE PHYSICIAN'S PRESCRIPTION OF AN ORAL ANTIBIOTIC FOR THE CUSTOMER WAS A PREVENTIVE MEASURE AND NOT AN INTERVENTION. IT WAS CLARIFIED IN AUGUST 2021 VIA EMAIL INQUIRY TO CDRH REQUESTING IF THE EVENT SHOULD BE SUBMITTED, THAT WHEN MEDICINE IS PRESCRIBED FOR AN EVENT, THE EVENT SHOULD BE REPORTED. THERE HAS BEEN NO PERMANENT OR LASTING INJURY REPORTED.

Description of Event or Problem

THIS WAS THE FIRST USE OF PHOTOTHERAPY BY THE CUSTOMER. THE PRESCRIBED TREATMENT REGIME WAS TREATMENT EVERY OTHER DAY. AFTER THE SECOND TREATMENT, THE CUSTOMER REPORTED REDNESS AND PEELING OF HIS LEGS. ONLY HIS LEGS WERE OVERTREATED, THE REST OF THE BODY DID NOT EXPERIENCE OVERTREATMENT. FOR HIS THIRD TREATMENT, THE PHYSICIAN SUGGESTED THE CUSTOMER COVER HIS LEGS, SO THEY WERE NOT EXPOSED TO THE PHOTOTHERAPY. THE CUSTOMER HAD HIS LEGS WRAPPED AND A PHYSICIAN PRESCRIBED ORAL ANTIBIOTIC TO PREVENT THE POSSIBILITY OF AN INFECTION OCCURRING.