MAUDE Adverse Event Report: BIOS S.R.L. SPLENDOR X; FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG)

Model Number	SPLENDOR X
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Bios received from the importer lumenis an adverse event report on patient who sustained burn at the legs area following treatment by splendor x 2.0 device.
Additional Manufacturer Narrative
Bios received the information from the importer lumenis the device ga-5000002us:(b)(6) was installed on (b)(6) 2025 and still under warranty.The service engineer visited the facility and performed energy checks for safety case.All energy was within range and machine is working properly.Nff.Device malfunction wasn't the suspected cause of the adverse event.The regional clinical expert evaluated this ae based on the provided data and advised as follows: "the importer lumenis received a report of an adverse event involving the splendor x.The injured patient is reported as a 40yo female, listed as (b)(6).Photos show medium-toned african american skin.This was this patient's first treatment.Settings are recorded as 18mm spot, bled alexandrite 5j yag 6j, pd not listed, cooling on (unspecified level), 2hz."immediately post treatment, the patient complained of pain, dizziness, darkening squares on the treated areas.24 hours post, the patient is reported to using hydrinity restorative serum and hyacin spray.48 hours post treatment the patient noted blistering and sought emergency room care.She was diagnosed with second degree burns.Photos demonstrate pih and compromised tissue on the bilateral full legs.9 - permanent injury resulting in permanent impairment."root cause failure: user error.No test patch was done.Inappropriate total fluence and alexandrite fluence for skin type.Failure to recognize unsatisfactory tissue response.Misdiagnosis of skin type and ethnicity.Possible effects: prolonged pih and hypopigmentation.Scarring and permanent pigment changes are possible." since the injury is serious (rated 9 out of 10), bios is reporting this case to the fda as manufacturer.

• Brand Name: SPLENDOR X
• Common Device Name: FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG)
• Manufacturer (Section D): BIOS S.R.L.; via guido rossa, 10/12; vimodrone (mi), italy 20055 ; IT 20055
• Manufacturer (Section G): BIOS S.R.L.; via guido rossa, 10/12; vimodrone (mi), italy 20055 ; IT 20055
• Manufacturer Contact: edoardo tronchet ; via guido rossa, 10/12; vimodrone (mi), italy 20055 ; IT 20055
• MDR Report Key: 23474100
• Report Number: 1720381-2025-00007
• Device Sequence Number: 18705282
• Product Code: GEX
• UDI-Device Identifier: 08052049500067
• UDI-Public: 08052049500067
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K243445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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: Other
• Device Model Number: SPLENDOR X
• Device Catalogue Number: GA-5000002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Female