Description of Event or Problem · 0
ON (B)(6) 2024, PATIENT, A 76-YEAR-OLD WOMAN, EXPERIENCED A SEVERE ADVERSE REACTION UPON WAKING UP THAT DAY. SHE WOKE UP TO FIND HER FACE SIGNIFICANTLY DISTORTED, WITH LUMPS, DARK AREAS, AND SWELLING. THE INTERNAL INFLAMMATION WAS SO SEVERE THAT IT MADE FLOSSING HER TEETH DIFFICULT DUE TO THE SWELLING INSIDE HER MOUTH. SHE HAD BEEN USING THE NIRA PRO DEVICE INTERMITTENTLY FOR THREE MONTHS. DESPITE HER CAREFUL USE, SHE DID NOT NOTICE ANY CHANGES UNTIL THE MORNING OF (B)(6) 2024, WHEN THE ADVERSE SYMPTOMS APPEARED SUDDENLY. SHE CLAIMS THAT THIS INFLAMMATION MAY BE THE RESULT OF THE NIRA LASER USE, HOWEVER THERE WAS NO DIRECT CONNECTION BETWEEN USING THE LASER FOR MANY MONTHS AND THIS PARTICULAR OVERNIGHT REACTION. IN AN ATTEMPT TO ADDRESS THE ISSUE, SHE VISITED HER DERMATOLOGIST, DR. (B)(6), ON (B)(6) 2024. DUE TO HER MEDICAL HISTORY, WHICH INCLUDES A PREVIOUS PERFORATED ULCER THAT PREVENTS HER FROM TAKING ANTI-INFLAMMATORIES, SHE WAS PRESCRIBED DOXYCYCLINE (100 MG, TWICE A DAY) AND OPZELURA CREAM. THE TREATMENT HAS LED TO SOME IMPROVEMENT, BUT AS OF (B)(6) 2024, SHE STILL EXPERIENCES SOME SWELLING AND BULGES ON HER FACE.