MAUDE Adverse Event Report: SCITON INC. MJOULE; POWERED LASER SURGICAL INSTRUMENT

Model Number	JOULE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Muscle Weakness/Atrophy (1967); Pain (1994); Skin Discoloration (2074); Blurred Vision (2137); Distress (2329); Superficial (First Degree) Burn (2685); Blister (4537)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch form, mw5146663, received from fda on 10/26/2023.Description of event: date of event: (b)(6) 2023."i was treated on (b)(6) 2023 with sciton mjoule forever young bbl (broad band light) hero (high energy rapid output).The treatment was directed at solar lentigines (sun spots) mostly on my left cheek but diffusely.I have fpst iii (fitzpatrick skin type 3).I did not use any retinoid before treatment and had no sun exposure.I followed all post treatment instructions.Treatment parameters as follows: 515 nm filter: 1st pass: fluence 6, pulse width 3, rate 4, chill temp 25c, total shots 214; 2nd pass: fluence 6, pw 3, rate 4, chill temp 25, total shots 400 spot treatment 7mm handpiece, 515 nm filter, fluence 12, pw 10, rate 1, chill temp 20c, total shots 654, spot treatment 11 mm 515 nm filter, fluence 12, pw 8, rate 1, chill temp 20, total shots 659 560 nm filter: 1st pass: fluence 6, pw 3, rate 4, chill temp 25, total shots 860; 2nd pass: fluence 6, pw 3, rate 4, chill temp 25, total shots 993; spot tx 7mm, fluence 20, pw 25, rate 1, chill temp 20, total shots 1054; spot treatment: 7mm handpiece, fluence 12 , pw 10, rate 1, chill temp 22, total shots 1199.Eyepiece was worn during treatment.Following this treatment, i noticed immediate redness and expected "peppering" of the skin.I had a blister over my left cheek.2 days later i started to notice enlarging pores, a strange "orange-peel" texture on my cheeks, and a "creepy" patch of skin on my forehead.Within 10-14 days, i started to notice pain around my eyes and malar cheeks.I then noticed atrophy of my cheeks and orbital skin, causing pain when closing my eyes and increased sensitivity.The fat atrophy progressed to involve my chin, jawline, buccal cheeks, temples and forehead.I had significant pain to require 1 er visit for orbital pain and blurry vision.The doctor who performed the treatment, dr.(b)(6), does not claim responsibility for her extremely over aggressive treatment despite obvious photo documentation showing the above findings.I have since had consultations with several cosmetic dermatologist and plastic surgeons who have recommended various treatment including fat transfer, biostimulatory fillers, hyaluronic acid fillers, and other lasers/microneedling to help with textural concerns and generalized volume loss.I still (5 months later) have significant burning of my facial skin, pain, and continued fat loss.The psychological ramifications are unbearable.I think this technology is faulty and should be taken off the market.I also feel the need for stricter training as the use of a 515 nm filter in fpst iii is negligent.The amount of passes also exceeds standard treatment protocols of 200-600 pulses for full face treatment.".
Additional Manufacturer Narrative
(b)(6) 2023: called patient and left voice message to call back.(b)(6) 2023: sciton received a phone call from the patient who mentioned that she was treated in (b)(6) 2023 by dr.(b)(6) at (b)(6).She has no medical history.Patient believes that the treatment settings were too aggressive for her skin type.Patient has not used any prescribed medications but has been consistently applying moisturizer.Patient reported feeling fine physically.(b)(6) 2023: called seriously skin and left message for dr.(b)(6) to call back.(b)(6) 2023: received call from dr.(b)(6) who mentioned that the patient is a healthy 34 years old female who runs 10 miles a day.The treatment was done during postpartum period while the patient was still on maternity leave.The settings were appropriate for the patient.The patient received a refund for the treatment cost.According to dr.(b)(6) records, patient outcome was good and no adverse outcome was noted during her three follow-ups.Dr.(b)(6) reported that the patient was doing well and was in good health.

• Brand Name: MJOULE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• 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: 18116769
• Report Number: 2953696-2023-00033
• Device Sequence Number: 18027573
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2023

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: JOULE
• Device Catalogue Number: 1500-001-60
• Device Lot Number: 50188
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female