BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPLENDOR X

    MDR report key: 22203338 · Received June 13, 2025

    Report

    Report Number
    1720381-2025-00001
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    May 20, 2025
    Report Date
    June 13, 2025
    Manufacturer
    BIOS S.R.L.
    Product Code
    GEX
    UDI-DI
    08052049500067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION COMES FROM (B)(4), THE BIOS IMPORTER/DISTRIBUTOR: (B)(4) INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. ATTEMPTS BY EMAILS AND PHONE CALLS HAVE BEEN MADE TO OBTAIN; PATIENT TREATMENT SETTINGS, PATIENT INFORMATION AND PATIENT PHOTO. INCIDENT FORM AND PATIENT PHOTOS HAVE BEEN RECEIVED IN (B)(4). AN EXAMINATION OF THE SUBJECT DEVICE WAS PERFORMED BY (B)(4) SERVICE ENGINEER. SERVICE ENGINEER HAS CONCLUDED: "THE CUSTOMER EXPRESSED CONCERNS REGARDING THE ND YAG TREATMENT FOR TELANGIECTASIAS AND VASCULAR LESIONS ON THE FACE, SPECIFICALLY IN RELATION TO SKIN TYPE II. ALL OTHER TREATMENT SETTINGS WERE REPORTED TO BE SATISFACTORY. AN EVALUATION WAS CONDUCTED, RESULTING IN A DECISION TO ADJUST THE BASELINE SETTINGS FOR THE ND YAG VASCULAR TREATMENT TO THE MIDDLE OF THE SPECTRUM. ADDITIONALLY, THE CUSTOMER ADVISED ADOPTING A MORE CONSERVATIVE APPROACH FOR SKIN TYPE II PATIENTS, PARTICULARLY FOR THOSE PRACTITIONERS WHO MAY LACK EXPERIENCE WITH THIS SKIN TYPE. THE SYSTEM'S AVAILABILITY FOR SERVICE WAS LIMITED DUE TO FULL-DAY BOOKINGS WITH CLIENTS. OVERALL, THECUSTOMER EXPRESSED SATISFACTION WITH THE CURRENT CONDITION OF THE SYSTEM." MORE PRECISELY AND BASED ON THE SERVICE MEASURING REPORT, THE BASELINE SETTINGS WERE STILL IN RANGE WITHIN THE UPPER ALLOWABLE LIMIT BEFORE THE ADJUSTMENT. HENCE, NO DEVICE MALFUNCTION WAS OBSERVED. THE SYSTEM WAS OPERATIONAL AND WAS READY FOR USE. THE DEVICE WAS INSTALLED ON (B)(6) 2025 AND STILL UNDER WARRANTY. DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. A (B)(4) CLINICAL HEALTHCARE DIRECTOR CONCLUDED: "(B)(4) RECEIVED A REPORT OF AN ADVERSE EVENT INVOLVING THE SPLENDOR X SYSTEM. PATIENT (B)(6) IS A 39YO FEMALE LISTED AS (B)(6). SHE WAS TREATED FOR IPL RESISTANT FACIAL TELANGIECTASIA ON THE BILATERAL NASAL ALA. THIS WAS THIS PATIENT'S FIRST TREATMENT ON THE SPLENDOR X. A PATCH TEST WAS NOT DONE, AND PRESETS WERE USED. THE PATIENT DENIED UV EXPOSURE AND IS REPORTED TO NOT HAVE ANY CONTRAINDICATIONS TO TREATMENT. SHE IS REPORTED AS TAKING CIPRALEX (ESCITALOPRAM) ORALLY EVERY DAY. THE TREATMENT SETTINGS ARE AS FOLLOWS: 5MM SPOTSIZE, 25MS PD, FLUENCE 110J, COOLING ON (NOT SPECIFIED WHAT LEVEL). POST TREATMENT, THE PATIENT REPORTED BLISTERING WOUNDS ON BOTH SIDES, WORSE ON THE RIGHT SIDE. INJURY PHOTO PROVIDED SHOW 3 WELL DEMARCATED, CIRCULAR, HEALING WOUNDS ON THE RIGHT NASAL ALA AND 1 RHINOLABIAL GROOVE. THE PHYSICIAN PRESCRIBED POLYSPORIN ANTIBIOTIC OINTMENT AND SCAR GEL. A PHOTO ON THE SAME AREA ONE MONTH POST TREATMENT SHOWS WELL HEALED TISSUE WITH SLIGHT DEPRESSED SCARRING. THE PHYSICIAN NOTED THAT HER VERY EXPERIENCED LASER TECHS STATED THE SPLENDOR X "RUNS HOT". CMDONE BY A (B)(4) CERTIFIED ENGINEER SHOWS THE DEVICE IS OPERATING WITHIN SPECS. THE ROOT CAUSE IS USER ERROR. THE TELANGIECTASIA SHOWN IN THE PRE-TREATMENT PHOTO SHOW VESSELS<0.5MM IN DIAMETER, SO THE USE OF THE 5MM SPOT SIZE WAS INAPPROPRIATE. ALSO, OF NOTE AS A POSSIBLE VARIABLE IS THE LACK OF TEST PATCH AND THE PATIENT IS ON ESCITALOPRAM, WHICH CAN BE LIGHT SENSITIZING. POSSIBLE EFFECTS: PERMANENT DEPRESSED SCARRING OF THE RIGHT NASAL ALA. THIS PATIENT MAY BENEFIT FROM RESURFACING TREATMENTS." THE HAZARD SEVERITY WAS RATED BY CLINICAL DIRECTOR AS 8 OUT OF 10 -PERMANENT INJURY WITH NO IMPAIRMENT. ACCORDING TO THE INFORMATION RECEIVED THERE WAS NO DEVICE MALFUNCTION FOUND. REGARDING THE CLINICAL EVALUATION THERE WAS A USER ERROR. THE TELANGIECTASIA SHOWN IN THE PRE TREATMENT PHOTO SHOWVESSELS <0.5MM IN DIAMETER, SO THE USE OF THE 5MM SPOT SIZE WAS INAPPROPRIATE. ALSO, OF NOTE AS APOSSIBLE VARIABLE IS THE LACK OF TEST PATCH AND THE PATIENT IS ON ESCITALOPRAM, WHICH CAN BE LIGHT SENSITIZING. FINALLY, THE HAZARD SEVERITY WAS RATED AS SERIOUS INJURY. A FEEDBACK LETTER HAS BEEN SENT TO THE CUSTOMER EXPLAINING HOW TO AVOID SUCH ISSUES IN THE FUTURE.

    Description of Event or Problem · 0

    (B)(4), THE BIOS S.R.L. DISTRIBUTOR, RECEIVED AN ADVERSE EVENT REPORT ON SEVERAL PATIENTS WHO SUSTAINED BLISTER AND SCAR AT THE FACE AREA FOLLOWING TREATMENT BY SPLENDOR X DEVICE. TWO INCIDENT FORMS HAVE BEEN RECEIVED IN (B)(4). THIS COMPLAINT WILL HANDLE PATIENT 1 OUT OF 2 WITH INITIALS- (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816146 SPLENDOR X FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG) GEX BIOS S.R.L. SPLENDOR X 1.0 08052049500067

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other