EXPECTED TREATMENT EFFECTS Sample Clauses

EXPECTED TREATMENT EFFECTS. Expected Treatment Effects Duration Bruising/Ecchymosis Up to 3 weeks Edema/Swelling Up to 2 weeks Erythema/Redness Up to 1 week Acute Pain Immediate/momentary (while energy is being delivered) - 2 hours Induration Up to 12 weeks Pruritus Up to 2 weeks Welting/Raised Areas of Edema Up to 4 weeks Skin Burn, Scarring, Change in pigmentation Up to 8 weeks Tenderness/Soreness/Pain/Sensitivity to Touch Up to 3 weeks /Muscle Twitching/Tingling/Paresthesia/Numbness Up to 5 weeks Reduced Range of Motion Up to 3 weeks Skin Peeling Up to 2 weeks Additional potential risks include: nerve injury, arterial blood spasm, change in axilla odor, and reduction of underarm hair growth. The risks from lidocaine with epinephrine may include pain and discomfort from the injections, infection at the anesthetic site, lightheadedness, nervousness, mood change, tinnitus, blurred vision, vomiting, sensations of heat, cold or numbness, tremors, seizures, or unconsciousness. Additional uncommon side effects may include bradycardia, hypotension and cardiac arrest. Allergic reactions may appear as skin rashes, swelling or anaphylaxis. Risk associated with a starch iodine test may include an allergic reaction to iodine solution or starch powder. No risks are anticipated from completion of a gravimetric sweat test or ultrasound imaging. These risks will be minimized or reduced by monitoring the subject during the treatment and observing the skin’s response to receiving the treatment. If the treatment is not tolerated, the investigator must stop administering treatment for the subject’s safety, and the subject will be followed for adverse events for 90 days. Previous clinical studies with the Ulthera® System have shown that the sensory response was tolerable from the subject’s and investigator’s perspectives. The discomfort was transient and no subject had any residual pain beyond 30 minutes.
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