BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPLENDOR X

    MDR report key: 23400496 · Received October 28, 2025

    Report

    Report Number
    1720381-2025-00006
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 28, 2025
    Manufacturer
    BIOS S.R.L.
    Product Code
    GEX
    PMA / PMN Number
    K161632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION BIOS RESULTS: BASED ON THE INFORMATION RECEIVED. THE DEVICE GA-5000000: SPXAY21N-261372 WAS INSTALLED AT THE FACILITY ON (B)(6) 2022, AND THE MOST RECENT PM WAS DONE ON (B)(6) 2025. THIS DEVICE IS UNDER CONTRACT. THE LUMENIS SERVICE ENGINEER TESTED THIS DEVICE AND ADVISED: ON (B)(6) 2025 INITIAL SYSTEM START AND INSPECTION SHOWS NORMAL FUNCTION. OUTPUT POWER CALIBRATION CHECK AT ALL OUTPUT POWERS ON CHECKLIST. TIP RECOGNITION OF ALL TIPS. FF." DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. INCIDENT FORM - RECORDED IN BIOS DOC FOLDER. CLINICAL EXPERT REPORT THAT THE INJURY IS SERIOUS (RATED 8). REGIONAL CLINICAL AND TRAINING EXPERT HAS REVIEWED THE CLINICAL DATA AND ADVISED AS FOLLOWS: "BIOS RECEIVED FROM LUMENIS A REPORT OF AN ADVERSE EVENT INVOLVING THE SPLENDOR X DEVICE ON THE VASCULAR LESION MODALITY. THE INJURED PATIENT IS REPORTED AS A 40YO FEMALE, FITZ III-IV. PHOTOS INCLUDED SHOW A PATIENT WITH MORE OLIVE-TONED SKIN INDICATING POSSIBLE FITZ IV. ETHNICITY IS NOT LISTED. THE PATIENT DENIED CONTRAINDICATIONS AND HAD ONE TREATMENT PRIOR WITHOUT SEQUELAE (DONE 4 WEEKS PRIOR TO THIS EVENT). PHOTOS AND NARRATIVE SHOW FROSTING AND CRUSTING OF THE RIGHT NASAL ALA. THE LEFT ALA WAS TREATED ALSO WITHOUT SEQUELAE. SETTINGS USED ARE REPORTED AS 5MM SPOT SIZE, 110J,20MS PD, COOLING ON. TWO WEEKS POST TREATMENT THE PATIENT WAS NOTED TO HAVE PIH AND CRATERED SCARRING ON THE RIGHT NASAL ALA. POST TREATMENT THE PATIENT WAS RECOMMENDED TOPICAL ANTIBIOTIC OINTMENT AND ONCE HYPERPIGMENTATION WAS IDENTIFIED, TOPICAL BLEACHING. RC: USER ERROR. TREATMENTS WERE DONE TOO CLOSE TOGETHER (4 WEEKS). THE PHOTOGRAPHS PROVIDED SHOW SMALL DIAMETER, SUPERFICIAL TELANGIECTASIA, THE 5MM SPOT SIZE WITH 20MS PD WAS LIKELY TOO LARGE FOR THE PROFILE OF THE LESIONS. THIS PATIENT HAS A DARKER SKIN TYPE, CONSERVATIVE SETTINGS AND PATCH TESTING SHOULD ALWAYS BE PRACTICED WITH FITZPATRICK IV-VI. POSSIBLE EFFECTS: TEMPORARY HYPERPIGMENTATION. SCARRING REQUIRES FURTHER PROCEDURES. 8 PERMANENT INJURIES WITH NO IMPAIRMENT.

    Description of Event or Problem · 0

    LUMENIS, OUR IMPORTER, RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED INJURY FOLLOWING TREATMENT BY SPX DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2735546 SPLENDOR X FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG) GEX BIOS S.R.L. SPLENDOR X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown