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(b)(6) 2025: sciton clinical spoke with clinic administrator on the phone regarding the reported adverse reaction with bbl heroic.Clinic administrator stated that the provider who performed the treatment was out of the office until next wednesday.Per clinic administrator, the patient had received a bbl heroic hair reduction treatment on the lower legs on (b)(6).It was reported that the patient experienced burns/blisters on the back of her legs but the front of her legs were unaffected.Clinic administrator stated that the provider treated her as a fitzpatrick 3 with the folliwng parameters: 640nm, 10j/cm2, 20ms, 10c, 1 pass, (b)(4).Post-care instructions were reviewed with the patient.Sciton clinical asked clinic administrator about the overlap and she stated that she did not have this information.Sciton clinical also asked for before pictures and clinic administrator stated that they did not have any.Clinic administrator stated that the patient did not have topical anesthetic and felt fine/comfortable during the procedure.Clinic administrator stated that adequate ultrasound gel was utilized as well.Sciton clinical asked clinic administrator about sun exposure and artifical spray tan.Clinic administrator stated that the patient appeared tan and may have been too tan to proceed with treatment.Clinic administrator stated that the patient had been treated before with the same parameters and had not had any concerns.Also, sciton clinical asked clinic administrator about her ethnicity and response to sun exposure and she stated that the patient was caucasian.Sciton clinical discussed with clinic administrator that she appears to be a darker fitzpatrick skin type and that a deeper penetrating filter would have been recommended.Also, stressed the importance of avoiding treating patients who have had sun and/or aritifical spray tan within the last 4 weeks.Sciton clinical discussed the importance of keeping the skin clean, moist with an occlusive such as aquaphor, and avoiding all sun exposure.Clinic administrator stated that the patient had just come into the office and per the doctor's orders was receiving a co2 lift mask along with silvadene cream and was wrapping with xerofoam gauze.Clinic administrator stated that the patient would repeat this saturday/ sunday and then come in on monday for a visit.Prior to ending the conversation, sciton clinical asked clinic administrator if she could set up a time next week to speak with the clinician, as she had several additional questions and wanted to discuss the patient case in more depth.Clinic administrator stated that would be great and sciton clinical told her that she would email her my availability.Before ending the call, clinic administrator stated that in the past the machine had a cooling issue and that service came out to check the system.She was curious as to if the cooling was still a concern and if that may have been the culprit for the complication.Sciton clinical told her the she would reach out to sciton service regarding this inquiry and follow up.After finishing the conversation, spoke with sciton tech support on the phone.Sciton tech support stated that the customer did not have a service report regarding a cooling concern.Sciton clinical emailed clinic administrator back and included sciton tech support on the email to ask clinic administrator when they had experienced the cooling concern, along with providing my availability for next week.(b)(6) 2025: sciton clinical had not heard back from clinic administrator, therefore, sent a follow up email to the clinic administrator to see how the patient was progressing with recovery.Sciton clinical also followed up regarding the cooling concern to see what timeframe it occurred.Included sciton tech support within the email to further assist her.Also, asked whether (b)(6) would be a good day to speak with the provider directly.(b)(6) 2025: clinic administrator responded and stated that the patient was seen yesterday and that the blisters had opened and that they would need to keep going to get the skin to turn over.She stated that the provider who treated the patient did not change any settings as the device set the overlap and cooling.She stated that the provider was out of town and would be back in the office, however, she was completey full since another provider was out.She stated that the provider is then out of the office again and has an active summer.She stated that the provider would be available on (b)(6) 2025 at 12:15 pm est.(b)(6) 2025: sciton clinical responed to clinic administrator and told her to continue with wound care measures including keeping the skin moist, clean, and avoiding all sun exposure.Sciton clinical told clinic administrator that she would be available on (b)(6) at 12:15 pm est.Reiterated that she was available if she needed any assistance prior to the call on (b)(6).(b)(6) 2025: clinic administrator responded to an email from sciton tech support asking about the cooling concern and stated that the provider would be available tomorrow to speak with sciton clinical.Per clinic administrator, the provider stated that the handpiece was hot to touch.Sciton tech support responded and stated that he was sending this case to schedule to plan a service visit.Sciton clinical responded to clinic administrator and stated that she would be available tomorrow from 9-12 pm pst or on friday (b)(6) after 1:30 pm mst.Clinic administrator responded and stated that she was not able to get ahold of the provider for the call and that we were set for a phone call on 8/1.(b)(6) 2025: clinic administrator sent an email to sciton service stating that she has continued to have ongoing issues with the mjoule device which was purchased in (b)(6).She stated that this was their third handpiece since initial purchase, and that they are demanding a brand-new handpiece along with an extension of the system's warranty.She stated that she wanted this matter escalated to senior leadership.Sciton tech support responded and included sciton tech support manager to the email.Sciton tech support manager responded and stated that they have reviewed the data sent from the system and have not seen anything that would suggest the temperature reading was off and/or that the handpiece operated outside of safe parameters.Sciton tech support manager stated that an on-site service visit was scheduled for (b)(6), along with a new handpiece.Sciton tech support manager stated that a warranty extension could be discussed after the visit.(b)(6) 2025: sciton clinical mailed sciton tech support manager to get an update regarding the service visit which took place on (b)(6).Also, emailed clinic administrator to check in on the patient's recovery and asked for additional photos of the patient.Clinic administrator responded and stated that the patient was doing well and that they were continuing to monitor her.Photos were included within the email.Sciton clinical responded to the clinic administrator's email and stated that recommendations would be to continue to keep the skin moist, clean, and avoiding all sun exposure.Also, confirmed that she would speak with the provider on (b)(6) at 12:15 pm est.(b)(6) 2025: sciton tech support manager contacted the clinic administrator to reassure that the system calibration with the new handpiece recently installed was within specification and based on the measurements taken by the engineer on (b)(6) there is no reason to believe that the previous handpiece delivered more energy than expected.The system is safe to use.(b)(6) 2025: sciton clinical spoke to the clinic provider on the phone at 12:15 pm est.The phone conversation lasted roughly 30 minutes.Sciton clinical ended the phone call by thanking clinic provider for discussing the patient case and stating that she is available if she needed any additional clinical assistance.After the phone call, sciton clinical sent the following email to sciton service detailing the entire phone conversation."i wanted to provide an update on this account.I spoke with the clinic provider this morning at 10:15 am mst.I asked her several questions regarding the patient case which occurred on (b)(6).Clinic provider stated that the patient received the burns/blisters on the posterior legs but nothing occurred on the anterior legs.Per clinic provider, she treated the patient as a fitzpatrick 3 (although when asking her ethnicity, she stated she was polish but did not know what else) and she utilized the following parameters: 10j/cm2, 10%, 20ms, 10c (1 pass).Prior to the call, we looked at iq and the settings for (b)(6) appear to be 14cm/2, 20%, 20ms, 15c, which are different from what was relayed.Default settings on the machine auto populate to 8j/cm2, 20ms, 10%, 13c.She stated that her first treatment on (b)(6) was these but that she began to increase to get clinical endpoint.I did state this to the provider and she stated that these settings were for the patient after her, although when looking at iq all the settings that day are higher than what she relayed.She did state that the patient has had 4 treatments and treatment 2-3 were the same settings and the patient's legs were the same color as the photos shown with no adverse reactions.No topical anesthetic was utilized, and adequate gel was utilized/ reapplied.Clinic provider stated that the patient did not have any discomfort during the treatment and the blisters/burns did not appear until 2 days post.I did ask about sun exposure/artificial tanning, and she stated that the patient did not have sun exposure.However, she stated that the mother does coach her son's soccer team which could have been a major reason for the sun exposure.I asked clinic provider for a before photo and she does not have one.I did voice to clinic provider that the patient appears tan and that there may have been sun exposure involved.Also, i stated that the patient appears to be a darker fitzpatrick skin type, therefore, a deeper penetrating filter (690nm) and more conservative parameters would have been recommended.Clinic provider understood this but posed the question on why there would have been an adverse reaction on the fourth treatment and not on the previous treatments.Clinic provider stated that the handpiece was leaking and that it could have been a culprit.I stated that a service visit was performed, and output was within specifications.I stated that a temperature error would have occurred as well.She stated that there was no error code but that the handpiece was hot to the touch, however, she did not see a leak.She stated that the leak could have been the cause of the handpiece being too hot, but i reiterated that a temperature error would have occurred.I said i would reach back out to sciton service to relay your concern and have them follow up as they would be able to answer any additional questions.Also, since the handpiece was replaced on (b)(6), i would reiterate to the account when reaching back out that all settings must be reverted back to safe start settings or all parameters reduced by at least 20%.At the end of the conversation, i asked her how the patient was healing.Clinic provider stated that the patient is healing well.She states that the legs are pink/hypopigmented, however, there are no more blisters present.The patient was utilizing a co2 lift mask for 3 days and now is on aquaphor/sunscreen.I reiterated proper wound care including aquaphor, sun exposure avoidance, and sunscreen.I told her she could reach out to me if she had any additional questions and/or concerns.Based on the phone conversation, i do believe this is due to clinician error rather than the machine itself.I believe it was a combination of skin typing, treatment parameters, and sun exposure.Please, feel free to reach out if you have any additional questions." (b)(6) 2025: sciton tech support manager sent an email to clinic administrator with the folloiwng information."thank you again for your time today.It was nice to talk to you.As discussed, after careful evaluation, we don't believe the machine caused the recent clinical adverse event.We have checked the calibration with the new bbl handpiece, and all numbers look good.The machine is safe to be used.".
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