BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE IQ

    MDR report key: 23643346 · Received November 25, 2025

    Report

    Report Number
    3001431138-2025-00011
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    October 3, 2025
    Report Date
    November 25, 2025
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    UDI-DI
    08057017760450
    PMA / PMN Number
    K193426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE AS MANUFACTURER OF THE DEVICE INVOLVED IN THE EVENT PERFORMED OUR OWN INVESTIGATION BASED ON THE INFORMATION SHARED BY THE US IMPORTER. THE US IMPORTER AND OUR CLINICAL DEPARTMENT HAVE EVALUATED ALL THE AVAILABLE INFORMATION AND CONCLUDED THE FOLLOWING: THE ACTUAL MEDICAL DEVICE INVOLVED IN THE EVENT HAS BEEN EVALUATED BY CYNOSURE'S AUTHORIZED TECHNICIAN, IN DATE 17/10/2025 AND FOUND WORKING PROPERLY WITHIN SPECIFICATIONS. THE US IMPORTER CONCLUDED THAT THE EVENT HAS BEEN CAUSED BY A USER ERROR WHERE THE PHYSICIAN USED TREATMENT'S PARAMETERS NOT ADEQUATE IN RELATION TO THE PATIENT'S CONDITIONS. ALL THE AVAILABLE INFORMATION HAS BEEN EVALUATED BY OUR CRP MANAGER WHO CONCLUDED THE FOLLOWING: HE AGREES WITH THE CONCLUSION MADE BY THE US IMPORTER, IN RELATION TO THE ROOT CAUSE, WHERE THE EVENT HAS BEEN CAUSED BY A USER ERROR IN WHICH THE PHYSICIAN HAVE NOT USED THE PROPER TREATMENT'S PARAMETERS. THE OPERATOR'S MANUAL, CODE OM122B1-D1_G.V07 (ACTUAL REVISION SHIPPED WITH THE DEVICE) CLEARLY IDENTIFIES PATIENT THAT HAVE RECENT SUN EXPOSURE AS CONTRAINDICATED FOR THE TREATMENT (CHAPTER 'CONTRAINDICATIONS'). BURNS ARE CLEARLY IDENTIFIED AS FORESEEABLE SIDE EFFECTS OF THE TREATMENT ON THE OPERATOR'S MANUAL, CODE OM122B1-D1_G.V07 (ACTUAL REVISION SHIPPED WITH THE DEVICE) AT CHAPTER 'ADVERSE EFFECTS'. THE ROOT CAUSE IDENTIFIED AS A USER ERROR IN WHICH THE PHYSICIAN FAILED TO EVALUATE THE PATIENT'S CONDITION AND PROCEEDED BY TREATING A TANNED AREA. BASED ON THE INVESTIGATION CARRIED OUT NO DESIGN ISSUES OF MALFUNCTION HAS BEEN FOUND TO BE CONTRIBUTORY TO THE EVENT. THAT SAID, NO ACTIONS HAS BEEN DEEMED NECESSARY. THE PRESENT MDR REPORT IS CONSIDERED AS A FINAL REPORT UNLESS FDA HAS MORE QUESTIONS ABOUT IT.

    Description of Event or Problem · 0

    IN DATE (B)(6) 2025 WE RECEIVE A COMMUNICATION FROM THE US IMPORTER, CYNOSURE, RELATIVE TO AN ADVERSE EVENT IN WHICH A PATIENT DEVELOPED BURNS FOLLOWING A HAIR REMOVAL TREATMENT, ON THE LEGS, WITH THE DEVICE ELITE IQ. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ, MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA, MARKETED IN THE USA WITH 510(K) K193426. THE EVENT TOOK PLACE AT (B)(6). THE PATIENT COMPLAINED WITH THE CLINIC ABOUT BURS THAT HAVE DEVELOPED ON THE TREATMENT AREA (LEGS) FOLLOWING THE HAIR REMOVAL TREATMENT. THE US IMPORTER, FOLLOWING THE INITIAL COMMUNICATION, PROCEED TO GATHER MORE DETAILED INFORMATION ABOUT THE EVENT. THE OPERATOR WHO PERFORMED THE TREATMENT ADMITTED THAT THE PATIENT WENT TO A VACATION IN (B)(6) AND THE TREATMENT AREA WAS STILL TANNED. OPERATOR REPORTED TO HAVE STARTED THE TREATMENT WITH THE YAG LASER SOURCE THEN CHANGED TO ALEX. ALEX LASER SOURCE IS NOT THE PROPER WAVELENGTH TO BE USED ON DARKER SKIN TYPES (SUCH AS TANNED SKIN). PARAMETERS USED FOR THE TREATMENT WERE: ALEX LASER SOURCE (755 NM), 15J/CM2, 20MS WITH 18MM HANDPIECE WITH ONE PASS. THE PATIENT WAS PRESCRIBED WITH BIAFINE CREAM AS PREVENTATIVE POST-TREATMENT CARE. PICTURES OF THE LESION WERE ALSO DISCLOSED IN WHICH IT IS CLEAR THAT THE PATIENT DEVELOPED BLISTERING AND BURNS ON THE AREA WITH THE WORST EFFECTS ON THE SHIN. THE PICTURES HAS BEEN REVIEWED BY BOTH THE US IMPORTER'S CLINICAL STAFF AS WELL AS OURS (AS MANUFACTURER OF THE DEVICE). THE LESION HAS BEEN EVALUATED AS A SERIOUS INJURY BECAUSE THEY MAY REQUIRE MEDICAL ATTENTION TO PREVENT A PERMANENT IMPAIRMENT. CYNOSURE, AS US IMPORTER OF THE DEVICE, HAVE ALREADY REPORTED THIS CASE TO THE US FDA WITH A DEDICATED MDR REPORT CODE MDR1222993-2025-00051 IN DATE OCTOBER THE 29TH, 2025. BASED ON THAT, IN ACCORDANCE WITH 21 CFR PART 803.50(B)(2) WE AS MANUFACTURER OF THE DEVICE ARE OBLIGED TO SUBMIT OUR OWN REPORT TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2851872 ELITE IQ ELITE IQ GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M122B1 08057017760450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other