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

Model Number	BBLS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blister (4537)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sciton clinical specialist explained to the clinic that the increased uv exposure during this season may have contributed to a heightened skin reaction due to possible tanning.On (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: 70's age, patient skin type: iv, treatment date: (b)(6) 2025, treatment performed by: nurse.Treatment details: full-face treatment.Filter: 590.Fluence: 9 j/cm².Pulse width: 20 msec.Cooling: 15°c.Adapter: 15×15.Shots: 155.Spot treatment for pigmented lesions.Filter: 560.Fluence: initially 11 j.Pulse width: 15-20 msec.Due to patient-reported pain, fluence was reduced to 10 j during the procedure.Total spot treatment shots: 52.Adverse event description: it was reported that immediately after the procedure, intense "popping" responses were observed on the heavily pigmented lesions treated with the 560 filter.Those areas became noticeably darker, and blister formation occurred.The patient was prescribed dexamethasone propionate 0.1% (mesaderm 0.1%), but no follow-up visit has taken place to date.The previous treatment on (b)(6) 2025, used the same parameters.After that session, the patient reported increased pigmentation.The cause was presumed to be post-treatment sun exposure and/or friction, resulting in pih (post-inflammatory hyperpigmentation).
Event or Problem Description
Patient: 70s age.Patient skin type: iv.Treatment date: on (b)(6) 2025.Treatment performed by: nurse.Treatment details: full-face treatment.Filter: 590.Fluence: 9 j/cm².Pulse width: 20 msec.Cooling: 15°c.Adapter: 15×15.Shots: 155.Spot treatment for pigmented lesions.Filter: 560.Fluence: initially 11 j.Pulse width: 15-20 msec.Due to patient-reported pain, fluence was reduced to 10 j during the procedure.Total spot treatment shots: 52.Adverse event description: it was reported that immediately after the procedure, intense "popping" responses were observed on the heavily pigmented lesions treated with the 560 filter.Those areas became noticeably darker, and blister formation occurred.The patient was prescribed dexamethasone propionate 0.1% (mesaderm 0.1%), but no follow-up visit has taken place to date.The previous treatment on (b)(6) 2025, used the same parameters.After that session, the patient reported increased pigmentation.The cause was presumed to be post-treatment sun exposure and/or friction, resulting in pih (post-inflammatory hyperpigmentation).
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: 22420637
• Report Number: 2953696-2025-00045
• Device Sequence Number: 8663373
• 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
• 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