BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE IQ

    MDR report key: 24936037 · Received April 21, 2026

    Report

    Report Number
    3001431138-2026-00004
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    October 26, 2025
    Report Date
    April 21, 2026
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    UDI-DI
    08034108510880
    PMA / PMN Number
    K193426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION REPORTED BY THE US IMPORTER, WE PERFORMED OUR OWN INVESTIGATION. MORE DETAILED INFORMATION ABOUT THE SERVICE HISTORY OF THE DEVICE HAS BEEN ASKED TO THE US IMPORTER, IN ORDER TO CLEARLY EXCLUDE THAT A MALFUNCTION COULD HAVE CONTRIBUTED TO THE EVENT. THE US IMPORTER INFORMED US THAT THE LAST SERVICE INTERVENTION PERFORMED ON THE DEVICE HAS BEEN DONE IN 2024 AND, SINCE THEN, THEY HAVE NOT RECEIVED ANY REQUEST FROM THE CLINIC RELATIVE TO ISSUES OR PROBLEM WITH THE DEVICE. THEY ALSO INFORMED US THAT, SINCE THE EVENT, THEY HAVE KEPT USING THE DEVICE REGULARLY WITHOUT ANY ISSUE. BASED ON THE INFORMATION AVAILABLE WE PERFORMED OUR ANALYSIS AND CONFIRMED THAT THE MOST PROBABLE CAUSE OF THE EVENT IS A USER ERROR IN WHICH THE PHYSICIAN HAVE NOT USED THE PROPER COOLING DURING TREATMENT BUT ONLY AFTER. THE CONCLUSIONS ABOVE WHERE MADE BASED ON THE ANALYSIS PERFORMED, WITH ALL THE DATA AVAILABLE, BY OUR CLINICAL MANAGER. HE ALSO CONFIRMED THAT ESION REPORTED BY THE PATIENT ARE A LITTLE SCARRING. ANYWAY THE ENTITY OF THE LESION (VERY LIMITED SURFACE) HAS BEEN EVALUATED TO NOT BEING CLASSIFIABLE AS A SERIOUS INJURY/SERIOUS DETERIORATION IN THE STATE OF HEALTH. THE CODES SELECTED IN SECTION H6 OF THE PRESENT REPORT HAVE TO BE CHOOSEN AS WORST-CASE SCENARIO AND IN ABUNDANCE OF CAUTION. MOREOVER, BURNS AND SCARRING ARE IDENTIFIED ON THE OPERATOR'S MANUAL CODE OM122A1-C1_G.11 (ACTUAL REVISION DELIVERED WITH THE DEVICE) AS FORESEEABLE SIDE EFFECT AT CHAPTER "SIDE EFFECTS". DESPITE OUR EVALUATION OF THE EVENT, AS NON REPORTABLE, WE PROCEED WITH THE SUBMISSION OF THE PRESENT MDR REPORT DUE TO THE FACT THAT THE US IMPORTER PROCEEDED WITH THE SUBMISSION OF THEIR OWN MDR REPORT, CODE 1222993-2026-00019 IN DATE APRIL THE 14TH, 2026 AND IN ACCORDANCE WITH 21 CFR PART 803.50(B)(2). NO MALFUNCTION NOR DESIGN ISSUE HAS BEEN FOUND TO BE CONTRIBUTORY TO THE EVENT. THE PRESENT MDR REPORT HAS TO BE CONSIDERED AS FINAL UNLESS FDA HAS MORE QUESTION ABOUT IT.

    Description of Event or Problem · 0

    ON DATE MARCH THE 23RD, 2026 THE US IMPORTER MADE US AWARE OF AN ADVERSE EVENT IN WHICH A PATIENT DEVELOPED SMALL SCARS FOLLOWING A VASCULAR TREATMENT WITH THE MEDICAL 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. IN THE COMMUNICATION RECEIVED BY THE US IMPORTER, IT IS REPORTED THAT THE PATIENT WAS UNDERGOING THE FOURTH TREATMENT, ON DATE (B)(6) 2025, WITH THE DEVICE PICOSURE AND THEN WAS TREATED FOR VASCULAR TREATMENT WITH DEVICE ELITE IQ. THE TREATMENT WITH THE ELITE IQ WERE PERFORMED ON DIFFERENT AREAS FROM THE ONES OF PICOSURE. IN THE COMMUNICATION ARE PROVIDED THE TREATMENT'S PARAMETERS USED WITH THE DEVICE ELITE IQ AS WELL AS PICTURES OF THE PATIENT FOLLOWING THE EVENT (ON OF WHICH AT 4 WEEKS FROM THE TREATMENT). TREATMENT PARAMETERS WERE 140J/CM2, 30MS, WITH 2.5MM HP. NO COOLING HAS BEEN USED DURING THE TREATMENT, ONLY POST. THE EVENT TOOK PLACE AT (B)(6) PLACED AT (B)(6), - AUSTRALIA. OUR CLINICAL AFFAIRS MANAGER EVALUATED THE CLINICAL INFORMATION AVAILABLE AND CONCLUDED THAT THE LESION REPORTED BY THE PATIENT ARE A LITTLE SCARRING. ANYWAY THE ENTITY OF THE LESION (VERY LIMITED SURFACE) HAS BEEN EVALUATED TO NOT BEING CLASSIFIABLE AS A SERIOUS INJURY/SERIOUS DETERIORATION IN THE STATE OF HEALTH. MOREOVER, BURNS AND SCARRING ARE IDENTIFIED ON THE OPERATOR'S MANUAL CODE OM122A1-C1_G.11 (ACTUAL REVISION DELIVERED WITH THE DEVICE) AS FORESEEABLE SIDE EFFECT AT CHAPTER "SIDE EFFECTS". WE EVALUATED THE EVENT AS NOT REPORTABLE (NO SERIOUS INJURIES REPORTED BY THE PATIENT AND NO HAZARDOUS MALFUNCTION HAS BEEN RECORDED), ANYWAY PROCEEDED TO SUBMIT THE PRESENT MDR REPORT DUE TO THE FACT THAT THE US IMPORTER HAVE SUBMITTED THEIR OWN MDR REPORT CODE 1222993-2026-0019 TO THE US FDA, WE WILL PROCEED WITH THE SUBMISSION OF THE EVENT IN ACCORDANCE WITH US FDA 21 CFR PART 803.50(B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251110 ELITE IQ ELITE IQ GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M122A1 08034108510880

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other