BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPLENDOR X

    MDR report key: 24976065 · Received April 24, 2026

    Report

    Report Number
    1720381-2026-00005
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 24, 2026
    Manufacturer
    BIOS S.R.L.
    Product Code
    GEX
    UDI-DI
    08052049500067
    PMA / PMN Number
    K161632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: AN EXAMINATION OF THE SUBJECT DEVICE WAS PERFORMED BY LUMENIS SERVICE ENGINEER AFTER VERIFYING ALL SYSTEM FUNCTIONS INCLUDING OUTPUT ENERGY VERIFICATION, ACCORDING TO LUMENIS TECHNICAL DOCUMENTATION. ALL OF THE PERFORMED TESTS PASSED. NO DEVICE MALFUNCTION WAS OBSERVED. THE SYSTEM WAS OPERATIONAL AND WAS READY FOR USE. THE DEVICE WAS INSTALLED ON (B)(6) 2024 AND NO PREVENTIVE MAINTENANCE WAS PERFORMED SINCE THEN. 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 8/10) A LUMENIS CLINICAL HEALTHCARE MANAGER CONCLUDED: "LUMENIS RECEIVED A REPORT OF AN ADVERSE EVENT INVOLVING THE SPLENDOR X FOR LASER HAIR REMOVAL. THE PATIENT IS A FEMALE FITZPATRICK VI, AGE UNKNOWN. THIS WAS HER FOURTH TREATMENT, PRIOR TREATMENT ON THE LEGS WITHOUT SEQUELAE. ON THE DATE OF INJURY, THE PATIENT RECEIVED LASER HAIR REMOVAL ON THE LEGS AND FACE. SETTINGS ARE REPORTED AS: LP YAG ONLY, 18MM SPOT SIZE, 10J, PD UNSPECIFIED, ZIMMER CHILLER ON 6 (REPORTED VIA EMAIL). A TEST SPOT WAS DONE ON THE INNER ARM 5 MINS PRIOR TO A FULL TREATMENT. TREATMENT WAS REPORTED AS UNEVENTFUL. DURING A FOLLOW UP CALL 2 DAYS POST TREATMENT, THE PATIENT REPORTED BLISTERING, BUT DID NOT SPECIFY LOCATION OR A DESCRIPTION. THE PATIENT IS REPORTED TO BE NONCOMMUNICATIVE WITH THE CUSTOMER AND PHOTOS WERE NOT OBTAINED. DUE TO LACK OF PHOTOS, PRE AND POSTCARE, PULSE DURATION, AN ACCURATE FULL ASSESSMENT IS NOT POSSIBLE. POSSIBLE EFFECTS: POSSIBLE FULL RECOVERY VS PROLONGED PIGMENTARY CHANGES VS SCARRING. EFFECTS ARE UNKNOWN DUE TO GAPS IN INFORMATION." RC: ROOT CAUSE NOT CONFIRMED. BASED ON THE AVAILABLE EVIDENCE, NO DEVICE MALFUNCTION WAS IDENTIFIED. THE EVENT IS CONSIDERED MOST LIKELY RELATED TO A USE ERROR DUE TO 5 MINUTES FROM PATCH TEST IS NOT ENOUGH TIME TO WAIT BEFORE STARTING THE TREATMENT. THE LITERATURE STATES THAT A PATCH TEST SHOULD BE DONE 48-72HOURS PRIOR TO A FULL PROCEDURE IN THE ANATOMICAL ZONE REQUESTED FOR TREATMENT. ADDITIONALLY, OTHER POSSIBLE USER ERROR COMPONENTS COULD INCLUDE: TOO SHORT PD. THERE ARE ALSO PATIENT VARIABLES THAT ARE UNKNOWN, BUT POSSIBLE CONTRIBUTORS TO THIS EVENT INCLUDING: UV EXPOSURE, USE OF SKIN SENSITIZING PRODUCTS LIKE RETINOLS, RETINOIDS, EXFOLIANTS, COMPROMISED SKIN BARRIER, UV EXPOSURE POST TREATMENT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200120 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