PANOSOL 3D
Received Sep 19, 2023 · Event occurred Aug 18, 2023
Report 1521608-2023-00001 · MDR key 17773675
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
51 YR · Female
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
PATIENT'S PHYSICIAN PRESCRIBED THE WRONG TYPE OF UNIT FOR THE PATIENT. ORDER FORM CALLED FOR NB-UVB UNIT BUT THE DOCTOR HAD BEEN TREATING PATIENT'S SCLERODERMA WITH UVA1 LIGHT THERAPY PRIOR. NB-UVB LIGHT IS SHORTER WAVELENGTH, HIGHER ENERGY LIGHT THAT REQUIRES SHORTER EXPOSURE TIMES THAN UVA1 LIGHT. RECOMMENDED EXPOSURE TIME PROVIDED BY PHYSICIAN (15 MIN) FAR EXCEEDED WHAT SHOULD BE USED FOR THIS TYPE OF UNIT. PATIENT TREATED HERSELF ONE TIME AND SUFFERED BURNS (EQUIVALENT TO SEVERE SUNBURN). DOCTOR'S OFFICE PERSONNEL MAY HAVE BEEN CONFUSED BY CHOICES ON FORM AS UVA1 IS NOT TYPICALLY OFFERED BY NATIONAL BIOLOGICAL. REQUIRES THE OFFICE TO SELECT "OTHER" ON THE FORM AND THEN SPECIFY UVA1. THEY INSTEAD SELECTED AN AVAILABLE CHOICE OF NB-UVB UNIT. ALTHOUGH PATIENT NOTES WERE PROVIDED THAT INDICATED UVA1 THERAPY, NATIONAL BIOLOGICAL DISPENSED THE NB-UVB PRODUCT AS PRESCRIBED. PATIENT DID NOT CONSULT PROVIDED OPERATIONS MANUAL AND INSTEAD USED DOCTOR'S RECOMMENDED TIME. DEGREE OF BURNS OVER ENTIRE BODY WAS NOT SPECIFIED, HOWEVER HER PHYSICIAN PRESCRIBED TRIAMCINOLONE OINTMENT AND HIGH STRENGTH (800MG) IBUPROFEN TO TREAT THE SYMPTOMS. PATIENT IS CURRENTLY RECOVERING (IN PEELING STAGE) AND WILL NOT CONTINUE PHOTOTHERAPY UNTIL SHE RECEIVES A UVA1 UNIT AND HER DOCTOR APPROVES HER CONTINUATION.
Additional Manufacturer Narrative
AWAITING RETURN OF DEVICE FROM PATIENT. NO EVIDENCE OF DEVICE MALFUNCTION, PATIENT RECEIVED INCORRECT PRESCRIPTION FOR SKIN CONDITION.