BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPLENDOR X

    MDR report key: 23474100 · Received November 5, 2025

    Report

    Report Number
    1720381-2025-00007
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 19, 2025
    Report Date
    November 5, 2025
    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

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2720765 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 Female Other