MAUDE Adverse Event Report: SCITON INC. MJOULE

Model Number	MJOULE
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Blister (4537)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Sciton clinical received a call from a provider reporting that a patient received an adverse reaction post-bbl on the face from treatment on (b)(6) 2026.
Additional Manufacturer Narrative
3/11/26: sciton clinical asked the provider to send an email with all revelant information including photos and treatment parameters by email.After reviewing the email, sciton clinical spoke with clinic pa-c on the phone.Clinic pa-c stated the patient received the procedure on monday and developed blisters on the face.On (b)(6) evening, the patient went to urgent care and they prescribed her a medrol dose pack and an antibacterial cream.Clinic pa-c stated that the patient was scheduled to come in later that day, (b)(6) for evaluation.The patient had previously come in for a bbl on (b)(6) and was treated as a fitzpatrick 3 with no concerns.Since the patient did not receive any significant changes, clinic pa-c decided to treat the patient as a fitzpatrick skin type 2 on 3/9.Clinic pa-c stated that the patient had no sun and/or artifical spray tan present.The following treatment parameters were utilized on the patient: face: base: 532 3/3/30/25.Pulse count: forehead 100 15x15, cheek 100 45/15, nose 60 15x15, chin/upper lip 80 15x15.Face reds: 560 13/20/20/20.Reds on nose: 560 15/15/20/15.Browns 515 13/15/10/15 ( 15x15) (2 diffuse passes).Lesion: 515 12/15/shot/15 11mm.During the phone conversation, sciton clinical discussed with clinic pa-c that the patient did appear to look darker than a fitzpatrick skin type 2.Also, discussed that the patient appeared tan but clinic pa-c stated that the patient had not received any recent sun exposure.When discussing treatment parameters, the pa-c stated that she was mostly utilizing dr.Bitter's treatment parameters.Sciton clinical discussed with her that these parameters will vary from sciton's protocol.Clinic pa-c was aware of this.When viewing the parameters, discussed that the overlap was higher, the pulse count was higher, and two passes were performed for diffuse pigmentation, however, only one is recommended.Sciton clinical discussed wound care measures including keeping the skin moist with an occlusive, avoiding sun exposure, and keeping the area clean.Clinic pa-c stated that she appreciated the sciton clinical's expertise and was very knowledgeable on wound care as she had been a wound care specialist for many years.She stated that she would follow up with the patient once she came into the clinic later that day.After the phone call, sciton clinical sent clinic pa-c the sciton heroic safe start protocol.Later that evening, sciton clinical received an additional email with picture's of the patients arms/hands showing red scabs.3/12/26: sciton clinical called clinic pa-c the following day to discuss the patient in further depth.Clinic pa-c stated that the patient did not come into the clinic yesterday afternoon and that the patient had reached out to her later that day with the pictures of her arms.Treatment parameters were as followed: chest: 515 5/3/30/20 700 pulses.Pigment: 515 15/15/shot/15.Hands: 515 7/20/10/15.Arms: 532 3/4/30/200.Pigment arms: 515 15/15; shot/15 similarily to the face, the arms/hands were treated as a fitzpatrick 2.Sciton clinical discussed that the patient appeared to be a darker fitzpatrick and discussed that the parameters utilized appeared to be more aggressive.Sciton clinical reiterated that the same wound measures should be implemented on the body as what was done on the face.3/17/26: sciton clinical emailed the clinic pa-c to inquire about the patient's recovery.3/18/26: clinic pa-c emailed back stating that she saw her last week and there was improvement, however, the patient will not come back in for another appointment.Xlinic pa-c stated that the patient is following all wound care recommendations that she discussed, however, she will not follow up in office.3/19/26: sciton clinical replied to clinic pa-c's email stating that she is glad that the patient is recovering well and that it will be important to reinforce proper wound care measures.Sciton clinical let her know that she is here for any additional clinical guidance should she have any questions.

• Brand Name: MJOULE
• Common Device Name: MJOULE
• Manufacturer (Section D): SCITON INC.; 925 commercial street; palo alto CA 94303
• Manufacturer (Section G): SCITON INC.; 925 commercial street; palo alto CA 94303
• Manufacturer Contact: jay patel ; 925 commercial street; palo alto, CA 94303 ; 6504939155
• MDR Report Key: 24811001
• Report Number: 2953696-2026-00057
• Device Sequence Number: 18812044
• Product Code: GEX
• UDI-Device Identifier: 00863249000329
• UDI-Public: 0863249000329
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MJOULE
• Device Catalogue Number: 1500-020-70
• Device Lot Number: 53505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/07/2026
• Date Device Manufactured: 10/17/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female