PANOSOL II 6 FT.
Received Jun 14, 2022 · Event occurred May 16, 2022
Report 1521608-2022-00002 · MDR key 14684146
Device
Product problems
- Patient Device Interaction Problem
Patient
29 YR · Female
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
PATIENT REPORTED THAT SHE WAS DIAGNOSED WITH 2ND DEGREE BURNS FROM OVERTREATMENT WHEN USING HER UV PHOTOTHERAPY DEVICE FOR THE FIRST TIME. THE PATIENT SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED WITH A TOPICAL STEROID (TRIAMCINOLONE) FOR TREATMENT.
Additional Manufacturer Narrative
NATIONAL BIOLOGICAL IS STILL IN THE PROCESS OF INVESTIGATING THIS INCIDENT. PATIENT CLAIMS TO HAVE USED MINIMUM EXPOSURE DOSAGE FOR SKIN TYPE III THAT SHE WAS DIAGNOSED AS. THE PATIENT WAS IN MEXICO PRIOR TO TREATMENT BUT CLAIMS NOT TO HAVE BEEN EXPOSED TO THE SUN WHICH COULD HAVE AFFECTED TREATMENT TIMES. THE PATIENT WAS ALSO RECOVERING FROM A SURGICAL PROCEDURE AFTER WHICH SHE WAS PRESCRIBED NSAIDS DRUGS FOR PAIN. THESE TYPES OF DRUGS CAUSE PHOTOSENSITIVITY IN SOME PATIENTS. ALSO INVESTIGATING WHETHER HER SKIN TYPE WAS ASSIGNED CORRECTLY. PATIENT CURRENTLY PLANS TO KEEP THE EQUIPMENT AND S WAITING FOR MORE INFORMATION BEFORE RESUMING TREATMENT.