BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPLENDOR X

    MDR report key: 23704491 · Received December 3, 2025

    Report

    Report Number
    1720381-2025-00008
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 2, 2022
    Manufacturer
    BIOS S.R.L.
    Product Code
    GEX
    UDI-DI
    08052049500067
    PMA / PMN Number
    K243445
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION BIOS RESULTS: BASED ON THE INFORMATION RECEIVED: THE DEVICE WAS INSTALLED ON (B)(6) 2025 AND STILL UNDER WARRANTY. AN EXAMINATION OF THE SUBJECT DEVICE WAS PERFORMED BY SERVICE ENGINEER AFTER VERIFYING ALL SYSTEM FUNCTIONS INCLUDING OUTPUT ENERGY VERIFICATION, FOUND ALL POWER PARAMETERS IN SPECIFICATION. NO DEVICE MALFUNCTION WAS OBSERVED. THE SYSTEM WAS OPERATIONAL AND WAS READY FOR USE. DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. INCIDENT FORM - RECORDED IN DOC FOLDER. CLINICAL EXPERT REPORT THAT THE INJURY IS SERIOUS (RATED 8). BIOS RECEIVED FROM LUMENIS A REPORT OF AN ADVERSE EVENT INVOLVING THE SPLENDOR X FOR VASCULAR TREATMENT. THE PATIENT IS A MALE FITZPATRICK II AND THE AREA TREATED WAS A LARGE CLUSTER OF VASCULARITY ON THE MEDIAL RIGHT LOWER LEG. THE SETTINGS ARE REPORTED AS LP YAG, 5MM SPOT SIZE, 100J, 30MS PD. IT IS REPORTED THAT THE ZIMMER CHILLER WAS NOT ON DURING THE FIRST 2-3 PULSES, AND THAT IS WHERE THE AREA OF INJURY ORIGINATED. THE PATIENT REPORTED IMMEDIATE DISCOMFORT. PHOTOS DEMONSTRATE A WELL DEMARCATED, DEEP AREA OF SCABBING AND ULCERATION WITH SURROUNDING ERYTHEMA AND EDEMA. THE PATIENT IS UNDER THE CARE OF A DERMATOLOGIST USING TOPICAL HEALING OINTMENT. PHOTOS SHOW A DENSE AREA OF VASCULARITY IN THIS AREA; THE TREATMENT APPROACH SHOULD HAVE BEEN VERY CAUTIOUS. POSSIBLE EFFECTS: SCARRING, INFECTION RC: USE ERROR: NO DEVICE MALFUNCTION FOUND. REGARDING THE CLINICAL EVALUATION THERE WAS A USER ERROR. USER FACILITY DIDN'T USE EXTERNAL COOLING DURING THE TREATMENT. ABUNDANT EXTERNAL COOLING IS ESSENTIAL DURING VASCULAR TREATMENTS. BIOS ASKED TO LUMENIS TO RETRAINING THE CLINICAL IN ORDER TO BE SURE THAT THE NEXT TIME THE PHYSICIAN WILL USE THE DEVICE CORRECTLY AS REPORTED IN THE USER MANUAL

    Description of Event or Problem · 0

    BIOS RECEIVED FROM ITS IMPORTER LUMENIS AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPLENDOR X 2.0 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2849810 SPLENDOR X FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG) GEX BIOS S.R.L. SPLENDOR X 08052049500067

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other