A physician¿s office reported that the patient experienced a burn on the face, following a thermage treatment.The available images were reviewed.The first image showed erythema, inflammation, and blisters on the right cheek and temporal area.In the second and third images, the blisters are resolved and hyperpigmented areas remain.The patient stated that there is scarring.The patient was treated with ice, hydrocortisone, desonide, and hydroquinone.The highest level of energy used was 3.5.The treatment tip was inspected prior to the treatment, without any abnormalities noted.The treatment tip was inspected after each treatment area.During the treatment of the right cheek, an abnormal sound was noted after about 300 reps, prompting an inspection of the tip.At this time, the treatment tip appeared abnormal.This was the first time this tip was used.
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A review of the manufacturing records showed all requirements were met.Based on the evaluation of the data log, the handpiece and system performed as expected during this treatment.There were a large number of technique issues discovered during treatment.These errors most likely did not cause this event.Service confirmed damage on the tip membrane.Based on the available information, the patient burns were most likely caused by the corner damage on the tip membrane.It is unknown how the damage to the treatment tip occurred.
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