BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPLENDOR X

    MDR report key: 22209497 · Received June 16, 2025

    Report

    Report Number
    1720381-2025-00003
    Event Type
    Injury
    Date Received
    June 16, 2025
    Date of Event
    May 1, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BIOS S.R.L.
    Product Code
    GEX
    UDI-DI
    08052049500067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IZ
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION COMES FROM LUMENIS, THE BIOS IMPORTER/DISTRIBUTOR: LUMENIS 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, PATIENT PHOTO. THE DEVICE IS SPLENDOR GA-5000000: (B)(6). IT'S BILLABLE AND BEING SERVICED BY THE DISTRIBUTOR. THEY ADVISED THAT THEY CHECKED THE OUTPUT POWER AND ITS IN NORMAL RANGE, CHECKED THE EARTHING AND IT IS NORMAL AS WELL. THEN THEY CHECKED ALL TIPS AND LENSES TO BE SURE ALL CLEAN. DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. ACCORDING TO THE CLINICAL EXPERT, THIS COMPLAINT SHOWS 4 DIFFERENT INJURED PATIENTS AND THEREFORE, THIS CASE WILL BE CLONED 3 TIMES AND EACH INJURED PATIENT WILL BE EVALUATED SEPARATELY. THIS COMPLAINT IS FOR PATIENT 3 OUT OF 4. "PT #3: DARKER SKIN (LIKELY (B)(6)) ON UNKNOWN AREA WITH A RELATIVELY WELL DEMARCATED PATCH OF SEVERE HYPERPIGMENTATION. SEVERITY 5 OR 8, PT WILL HAVE LASTING AND POSSIBLE PERMANENT HYPERPIGMENTATION." BASED ON THE PROVIDED DATA, THERE IS NO CONCLUSIVE EVIDENCE THAT THE INJURY WAS CAUSED BY A MALFUNCTION OF THE DEVICE OR ITS COMPONENTS. HOWEVER, A PARTIAL CLINICAL EVALUATION INDICATES THAT THE INJURY MAYBE POTENTIALLY SERIOUS, DEPENDING ON FURTHER DEVELOPING. THEREFORE, LUMENIS IS REPORTING THIS EVENT TO THE FDA BECAUSE OF THE SEVERITY OF THE INJURY AS AN IMPORTER. SHOULD ADDITIONAL SIGNIFICANT INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. NEVERTHELESS, DUE TO THE LACK OF INFORMATION, IT IS NOT POSSIBLE TO ESTABLISH A ROOT CAUSE FOR THE ADVERSE EVENT (AE) OR DEFINE USER ERROR. THEREFORE, NO FEEDBACK LETTER IS NEEDED. BIOS CONFIRMED TO REPORT THIS EVENT ALSO AS MANUFACTURER AND DUE TO THE LACK OF INFORMATION, IT IS NOT POSSIBLE TO ESTABLISH A ROOT CAUSE FOR THE ADVERSE EVENT (AE) OR DEFINE USER ERROR. THEREFORE, NO FEEDBACK LETTER IS NEEDED.

    Description of Event or Problem · 0

    LUMENIS, THE BIOS S.R.L. DISTRIBUTOR, 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
    1540166 SPLENDOR X SPLENDOR X ALEX+ND:YAG GEX BIOS S.R.L. SPLENDOR X 1.0 08052049500067

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other