inforMED
InjuryFTC

PANOSOL 6-3D

Received Dec 13, 2024 · Event occurred Dec 3, 2024

Report 1521608-2024-00003 · MDR key 20925440

Device

Generic name

Uv Phototherapy Device

Model number

UVB-680

Product problems

  • Use of Incorrect Control/Treatment Settings
  • Use of Device Problem
  • Use of Incorrect Control/Treatment Settings
  • Use of Device Problem

Patient

24 YR · Female

  • Burn(s)
  • Burn(s)

Narrative

Description of Event or Problem

PATIENT HAS BEEN DIAGNOSED WITH PSORIASIS VULGARIS (L40.0). HER DOCTOR PRESCRIBED THE USE OF A PANOSL 63D (ULTRAVIOLET LIGHT THERAPY SYSTEM) TO TREAT HER CONDITION AT HOME BECAUSE OF FREQUENT FLAREUPS OF THE DISEASE. PATIENT WAS ADVISED THAT SHE WOULD NEED 2-3 TREATMENTS PER WEEK AND THAT SHE WOULD BE CONTACTED BY A DOCTOR TO PROVIDE MORE DETAIL REGARDING HER TREATMENT PROTOCOL. UPON RECEIPT OF HER EQUIPMENT, THE PATIENT STILL HAD NOT RECEIVED THE CALL FROM THE PHYSICIAN AND DECIDED TO BEGIN TREATMENT ON HER OWN. USING HER PREVIOUS TANNING EXPERIENCE AS A BASELINE, THE PATIENT DECIDED TO USE AN INITIAL TREATMENT TIME OF SEVEN MINUTES. SHE DID NOT REFER TO THE RECOMMENDED PROTOCOLS INCLUDED IN THE DEVICE OPERATIONS MANUAL NOR CONSULT HER PHYSICIAN OR NATBIO PRIOR TO THE TREATMENT. THIS ARBITRARY TREATMENT TIME DOES NOT CORRESPOND TO THE RECOMMENDED PROTOCOL FOR HER SKIN TYPE (FITZPATRICK SKIN TYPE II) NOR ANY OTHER PHOTOTHERAPY PROTOCOL. AS A RESULT, THE PATIENT RECEIVED FIRST DEGREE BURNS ACROSS HER BODY. SHE SOUGHT TREATMENT FOR HER BURNS AT A LOCAL EMERGENCY ROOM AND WAS PRESCRIBED IBUPROFEN AND PYREGESIC TO TREAT THE INJURIES. HER CURRENT CONDITION IS MUCH IMPROVED WITH SKIN REDNESS AND SWELLING HAVING SUBSIDED. THE PATIENT IS EAGER TO RETURN TO PHOTOTHERAPY TREATMENTS AND WILL RECOMMENCE UPON MEETING WITH HER DERMATOLOGIST.