MAUDE Adverse Event Report: SCITON, INC. JOULE; BBL AND HALO

Model Number	1500-033-20
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	06/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2017, (b)(4) (rn) discussed the clinical complaint letter received by sciton with (b)(6) at dr.(b)(6)'s office and reported the following: (b)(6) has attended numerous dr.(b)(6) courses, and utilized his settings for ethnic skin.·her settings were congruent with those he indicates for fitz v.·the guest immediately returned after her initial burn, and was treated following their burn protocol (aquaphor, etc).·she was initially put on hq nightly after the burned healed.·(b)(6) then reached out to dr.(b)(6), who advised her to put her on kojic acid, hq 6% and retin-a.·he advised her to do this for only "one hour" at night - i have never heard of this protocol before.·the patient then returned and (b)(6) did a light bbl with a spot treatment as advised by dr.(b)(6).·(b)(6) then tried a mlp, and a halo w/1470 only to the spots -as advised by dr.(b)(6).·the guest then was sent out to a dermatologist for evaluation, and was told that you should "never use a halo on darker skin types".(b)(6) explained this upset her, as the dermatologist has no laser experience, and neither does dr.(b)(6).She stated that the patient had always been nice and seemed understanding, and that she had asked for our contact information on her last visit b/c she told them she would be reaching out to us.I told (b)(6) that we would not be reaching out to the client, but that i wanted to her to be aware of the correspondence.·i also took time to advise her that even though her settings were congruent with (b)(6)'s, the patient actually appeared to be more of a fitz v +, meaning that i would not advise using the bbl due to overheating and the possibility of it causing a thermal event.·i steered her towards dr.(b)(6)'s archived webinar for treating melasma, which also covers darker skin types.·i advised that the 1470nm only treatment was approved for st i - v, and that the combined modalities were actually safer for darker skin.(b)(6) will be going to the user summit, and i will have time to also chat with her in person.I suggested having clinical come in for another training session, if dr.(b)(6) thought this would be appropriate.On (b)(6) 2017, (b)(6) contacted dr.(b)(6)'s patient to inform her that sciton had forwarded her letter and photographs to dr.(b)(6)'s office for further evaluation, and also informed her that (b)(4) (sciton rn) had contacted dr.(b)(6)'s practice to further investigate this event and learned at that time that the practice had previously reached out to dr.(b)(6) in (b)(6).Dr.(b)(6)'s patient was also informed that since sciton is not licensed to practice medicine it cannot provide her medical advice.Dr.(b)(6)'s patient indicated that she currently has one large dark spot and couple of small spots on one side of her face.She has been consulting with a dermatologist who has her on skin bleaching and steroid treatment.She indicated that she believes her skin condition is improving.
Event or Problem Description
Patient had bbl and halo procedures in (b)(6) 2016 at (b)(6).The patient reported that the results were disastrous; instead of improving the patient's skin, it burned the skin in several areas, despite using settings recommended for ethnic dark skin for asian indian skin.Patient also reported that after one year, she still has prominent dark spots which she is unable to conceal with make-up, and also reported that there are marks left by the spots that faded.

• Brand Name: JOULE
• Common Device Name: BBL AND HALO
• Manufacturer (Section D): SCITON, INC.; 925 commercial street; palo alto CA 94303
• MDR Report Key: 7438534
• Report Number: 2953696-2017-00021
• Device Sequence Number: 1055749
• Product Code: GEX
• UDI-Device Identifier: 00863249000305
• UDI-Public: 00863249000305
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2017

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: Physician Assistant
• Device Model Number: 1500-033-20
• Device Catalogue Number: JOULE
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 YR
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention