BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPLENDOR X

    MDR report key: 18341761 · Received December 17, 2023

    Report

    Report Number
    3020611964-2023-00017
    Event Type
    Injury
    Date Received
    December 17, 2023
    Date of Event
    November 20, 2023
    Report Date
    December 17, 2023
    Manufacturer
    BIOS SRL
    Product Code
    GEX
    UDI-DI
    08052049500067
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 AND PATIENT PHOTO. NO INCIDENT FORM OR PATIENT PHOTO HAS BEEN RECEIVED IN LUMENIS. AN EXAMINATION OF THE SUBJECT DEVICE WAS PERFORMED BY LUMENIS SERVICE ENGINEER AFTER VERIFYING ALL SYSTEM FUNCTIONS INCLUDING INSIDE AND OUT UNIT INSPECTION. VERIFICATION OF ALIGNMENT OF THE HANDPIECE. OUTPUT ENERGY VERIFICATION. THE SUBJECT DEVICE OPERATED WELL WITHIN LUMENIS SPECIFICATIONS. NO DEVICE MALFUNCTION WAS OBSERVED. THE SYSTEM WAS OPERATIONAL AND WAS READY FOR USE. THE DEVICE WAS INSTALLED ON (B)(6) 2023 AND STILL UNDER WARRANTY. DEVICE MALFUNCTION WASN'T THE SUSPECTED CAUSE OF THE ADVERSE EVENT. CLINICAL EVALUATION WASN'T PERFORMED, SINCE NO INCIDENT FORM OR PHOTOS WERE SENT TO LUMENIS. WHILE THE INFORMATION RECEIVED TO DATE DOES NOT CONFIRM THAT A SERIOUS INJURY NOR MALFUNCTION HAD OCCURRED, BECAUSE OF THE LACK OF INFORMATION LUMENIS IS REPORTING THE EVENT IN AN 'ABUNDANCE OF CAUTION'. SHOULD ADDITIONAL SIGNIFICANT INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY, AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. LUMENIS IS NOT THE MANUFACTURER OF THE SPLENDOR X DEVICE WHICH WAS USED DURING THIS PROCEDURE, LUMENIS HAS FORWARDED THE INFORMATION OF THIS EVENT TO THE LEGAL MANUFACTURER AND IS CLOSING THIS COMPLAINT.

    Description of Event or Problem · 0

    LUMENIS RECEIVED 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
    1548520 SPLENDOR X FAMILY OF SQUARE EPIL (ALEX, ALEX2, ND:YAG, ALEX+ND:YAG) GEX BIOS SRL SPLENDOR X 08052049500067

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other