Description of Event or Problem · 0
CUSTOMER PERFORMED 3 PULSES ON A TEST SPOT TO THE BACK OF THE HAND DURING TRAINING (B)(6) 2026 AND REPORTED A BURN IN THE AREA THE FOLLOWING DAY. PARAMETERS USED FOR THE TREATMENT (PATIENT'S CONDITION IN THE TREATMENT AREA BEFORE THE TREATMENT, SETTINGS USED DURING TREATMENT): 1 PASS, 8J, PULSE WIDTH 25, PULSE DELAY 50, 3 PULSES. PATIENT'S TREATMENT ENDPOINT IMMEDIATELY AFTER TREATMENT: ERYTHEMA, BURNING, STINGING, RAISED POST TREATMENT CARE: VASELINE AND 1% HYDROCORTISONE CREAM. WERE OTHER PATIENTS TREATED BEFORE OR AFTER WITH THE SYSTEM? NO AS DESCRIBED IN THE TREATMENT PROTOCOL PROVIDED WITH THE INSTRUCTIONS FOR USE, PATCH TESTS SHOULD BE PERFORMED, IN THE TREATMENT AREA, NOT ON THE HAND. FURTHERMORE, THE IFU STATES, CONSECUTIVE PULSES SHOULD NOT BE PERFORMED IN THE SAME AREA, WITHOUT ADJUSTING THE HEAD TO A DIFFERENT PLACE ON THE SKIN DURING LASER TREATMENT DUE TO THE RISK OF INTENSIFICATION OF POST-INFLAMMATORY HYPERPIGMENTATION AND BURNS. THERE IS A RISK OF SIDE EFFECTS FROM OVER-TREATMENT/OVER-HEATING IN THE FORM OF REDNESS (ERYTHEMA), SWELLING (EDEMA), SKIN COLOR CHANGES (HYPERPIGMENTATION, OR HYPOPIGMENTATION), BURNING, BLISTERING, AND SCARRING. PROLONGED OR IMPROPER USE OF THE DEVICE, SUCH AS EXCESSIVE POWER SETTINGS OR INCREASED NUMBER OF PASSES, MAY INCREASE THE RISK OF INJURY. THE IFU ALSO STATES TO NOT USE THE LASER WITHOUT FIRST APPLYING THE TREATMENT GEL TO CLEAN, DRY SKIN. A CLEAR (TRANSPARENT) AND COLORLESS (FREE OF DYE) ULTRASOUND GEL SHOULD BE USED. THE APPLICATOR MAY NOT OPERATE PROPERLY IF USED WITHOUT THE GEL, OR IF USED WITH ANOTHER LOTION OR GEL. THERE COULD BE LOTIONS ON THE HAND THAT COULD CAUSE SKIN IRRITATION OR DISCOMFORT. COFA AND MANUFACTURING RECORD REVIEWED FOR THIS DEVICE AND NO ISSUES WERE NOTED. BASED ON THE NATURE OF THE REPORTED EVENT, THE INJURY IS UNLIKELY TO QUALIFY AS A SERIOUS INJURY AS DEFINED BY 21 CFR 803.3(W) BUT THIS EVENT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.