MAUDE Adverse Event Report: SCITON INC. BBLS; IPL DEVICE

Model Number	BBLS
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Blister (4537)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sciton clinical specialist provided an explanation to the attending nurse regarding the inappropriate use of the 590 filter for the patient with fitzpatrick skin type v.It was also explained that the increased uv exposure during this season may have contributed to a heightened skin reaction due to possible tanning.(b)(6) 2025: sciton clinical specialist followed up with the clinic, and it was reported that the patient has not returned for a consultation.The clinic informed the patient that a follow-up visit is not necessary unless the symptoms worsen.They also mentioned that they have not received any further calls or inquiries from the patient.
Event or Problem Description
Patient: male, 50s.Skin type: v.Treatment date: (b)(6) 2025.Performed by: nurse.Treatment details: full-face treatment.Filter: 590.Fluence: 11 j/cm².Pulse width: 20 msec.Cooling temperature: 15°c.Adapter: 15×15.Passes: 1.Shots: 182.Spot treatment for multiple pigmented lesions.Filter: 560.Fluence: 15 j × 3 shots.Mode: spot treatment.Shots: 182.Numerous pigmented lesions.Adverse event description: no discomfort was reported during the procedure.On the following day, blister formation occurred on the right forehead at the location of a dark pigmented lesion that had received spot treatment with the 560 filter.The patient visited the clinic the following day, where betamethasone valerate 0.12% (lindelone vc 0.12%) was applied topically.Additionally, hydrocortisone butyrate 0.1% (locoid 0.1%) was prescribed for use at home.Upon follow-up on june 18, the lesion showed significant improvement with minimal post-inflammatory hyperpigmentation (pih) and no visible scarring.Previous treatment: previous session on (b)(6) 2025.The same parameters as those used on (b)(6) 2025, were applied for full-face treatment.Pigmented lesion spot treatment at that time used the 560 filter with fluences of 14 j, 15 j, and 20 j - no adverse events reported.
Event or Problem Description
Patient: male, 50s skin type: v.Treatment date: (b)(6) 2025.Performed by: nurse.Treatment details: full-face treatment.Filter: 590.Fluence: 11 j/cm².Pulse width: 20 msec.Cooling temperature: 15°c.Adapter: 15×15.Passes: 1.Shots: 182.Spot treatment for multiple pigmented lesions.Filter: 560.Fluence: 15 j × 3 shots.Mode: spot treatment.Shots: 182.Numerous pigmented lesions.Adverse event description: no discomfort was reported during the procedure.On the following day, blister formation occurred on the right forehead at the location of a dark pigmented lesion that had received spot treatment with the 560 filter.The patient visited the clinic the following day, where betamethasone valerate 0.12% (lindelone vc 0.12%) was applied topically.Additionally, hydrocortisone butyrate 0.1% (locoid 0.1%) was prescribed for use at home.Upon follow-up on june 18, the lesion showed significant improvement with minimal post-inflammatory hyperpigmentation (pih) and no visible scarring.Previous treatment: previous session on (b)(6), 2025.The same parameters as those used on (b)(6), 2025, were applied for full-face treatment.Pigmented lesion spot treatment at that time used the 560 filter with fluences of 14 j, 15 j, and 20 j - no adverse events reported.
Additional Manufacturer Narrative
Follow-up 1: new information received notes that the patient returned for a follow-up consultation.The patient condition is improving, and matter is considered resolved.

• Brand Name: BBLS
• Common Device Name: IPL DEVICE
• 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: 22420639
• Report Number: 2953696-2025-00044
• Device Sequence Number: 8663374
• Product Code: GEX
• UDI-Device Identifier: 00863249000312
• UDI-Public: 0863249000312
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K070388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: BBLS
• Device Catalogue Number: 1500-067-30
• Device Lot Number: 31075
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2021
• 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
• Patient Sex: Male