BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONDA PRO

    MDR report key: 24257364 · Received February 4, 2026

    Report

    Report Number
    3001431138-2026-00001
    Event Type
    Injury
    Date Received
    February 4, 2026
    Date of Event
    February 1, 2026
    Report Date
    February 4, 2026
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    PBX
    UDI-DI
    08034108511115
    PMA / PMN Number
    K211091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN ORDER TO GATHER MORE DETAILED INFORMATION WE ASKED THE DISTRIBUTOR TO CONTACT THE CLINIC IN ORDER TO HAVE ALL THE CLINICAL INFORMATION USEFUL FOR THE INVESTIGATION. THE DISTRIBUTOR REPLIED TO OUR REQUEST BY REPORTING THE FOLLOWING: THE CLINIC IS UNRESPONSIVE DUE TO THE FACT THAT, DURING THE EVALUATION OF THE DEVICE, REPORTED TO HAVE USED LOCAL ANESTHETIC IN THE TREATMENT AREA WHICH IS CONTRAINDICATED. MOREOVER THEY REPORTED THAT THE HANDPIECE USED FOR THE TREATMENT IS THE SHALLOW WITH POWER 120W. NO CLEAR INFORMATION ABOUT THE INTENDED TREATMENT HAS BEEN DISCLOSED SO IT IS NOT POSSIBLE TO EVALUATE CLEARLY IF THE EVENT REPRESENTS AN ABNORMAL USE. THE ACTUAL DEVICE HAS BEEN EVALUATED BY THE DISTRIBUTOR WITH ITS AUTHORIZED TECHNICIAN AND FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS. WE AS MANUFACTURER OF THE DEVICE INVOLVED IN THE EVENT PERFORMED OUR OWN INVESTIGATION BASED ON THE INFORMATION SHARED BY THE TAIWANESE DISTRIBUTOR AND CONCLUDED THE FOLLOWING: ALL THE AVAILABLE INFORMATION HAS BEEN EVALUATED BY THE CLINICAL AFFAIRS MANAGER WHO CONCLUDED THE FOLLOWING: THE EVENT IS A CLEAR USER ERROR, ASSUMING THAT THE DEVICE HAS BEEN USED WITHIN CLEARED INTENDED USE, DUE TO THE FACT THAT: 1) FACE AND NECK ARE AREAS TO BE EXCLUDED FROM THE TREATMENT AS SPECIFIED ON THE OPERATOR'S MANUAL CODE OM116J1_G.V05 - ACTUAL DEVICE INVOLVED IN THE EVENT AT CHAPTER 11.4.3 "AREAS TO BE EXCLUDED FROM THE TREATMENT"; 2) PHARMACOLOGICALLY ANAESTHETISED AREAS (ABSENCE OF PATIENT FEEDBACK ON PAIN) ARE AREAS TO BE EXCLUDED FROM THE TREATMENT AS SPECIFIED ON THE OPERATOR'S MANUAL CODE OM116J1_G.V05 - ACTUAL DEVICE INVOLVED IN THE EVENT AT CHAPTER 11.4.3 "AREAS TO BE EXCLUDED FROM THE TREATMENT"; 3) THE TAIWANESE DEVICE IS NOT EVEN CLEARED FOR THE TREATMENT ON THE SUBMENTAL AREA (WHICH IS CLEARED ON OTHER ONDA MODELS) AND, ANYWAY, FOR SUCH AREAS IS REQUIRED TO USE THE POCKED HANDPIECE WHICH CANNOT REACH POWER ABOVE THE 100W. THAT SAID, IN ADDITION TO THE ABOVE LISTED USER ERRORS, THE TREATMENT WAS PERFORMED WITH THE WRONG HANDPIECE AND WITH WAY TOO MUCH AGGRESSIVE PARAMETERS. SO, IT WOULD HAVE BEEN ALSO A USER ERRORS IN THE COUNTRIES WHERE SUBMENTAL TREATMENT IS CLEARED. THE ROOT CAUSE OFTHE EVENT HAS BEEN FOUND TO BE SOLELY A USER ERROR WHERE THE PHYSICIAN PERFORMED THE TREATMENT CONTRAINDICATED AREA. NO MALFUNCTION NOR ANY DESIGN ISSUE HAS BEEN FOUND TO BE CONTRIBUTORY TO THE EVENT. THE DEVICE HAS BEEN FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS. THE RISK MANAGEMENT FILE OF THE DEVICE, CODE RMF_M116X1 IN REVISION 09 HAS BEEN EVALUATED, FOR THE RISK RELATIVE TO INJURY TO PATIENT DUE TO A USER ERROR (TREATMENT OF CONTRAINDICATED AREAS) AND FOUND STILL ADEQUATE ON BOTH THE SEVERITY AND PROBABILITY POST-MITIGATION.BASED ON THE ASSESSMENT ABOVE MENTIONED NO UPDATE ON THE RISK MANAGEMENT FILE IS REQUIRED. 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 06TH JANUARY 2026 WE RECEIVE A COMMUNICATION FROM THE TAIWANESE DISTRIBUTOR (GRAND MEDICAL CO. LTD), RELATIVE TO AN ADVERSE EVENT IN WHICH A PATIENT DEVELOPED MILD BURNS FOLLOWING A TREATMENT WITH THE DEVICE ONDA ON THE CHEEK. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ONDA, MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA, MARKETED IN THE USA WITH 510(K) K2110916. IN ORDER TO BE MORE SPECIFIC ABOUT THE ACTUAL DEVICE INVOLVED IN THE EVENT WE PRECISE THAT THE TAIWANESE MODEL OF THE DEVICE ONDA HAVE A LIMITED INTENDED USE TO THE ONDA MODEL MARKETED IN OTHER TERRITORIES. IN FACT, THE TAIWANESE MODEL IS CLEARED ONLY FOR THE INTENDED USES RELATIVE TO THERAPEUTIC HEATING AND NOT TO BE USED ON THE HEAD AND NECK. THE EVENT TOOK PLACE AT MERNA CLINIC , 4 F, NO. 321, FU-HSING SOUTH ROAD, SEC. 1, DA-AN DISTRICT, TAIPEI, TAIWAN . THE INITIAL INFORMATION REPORTED BY THE DISTRIBUTOR WERE VERY LIMITED, ESPECIALLY RELATIVE TO THE TREATMENT PARAMETERS AND DETAILS. IN FACT, THE INITIAL COMMUNICATION, ONLY REPORTED THE PICTURES OF THE PATIENT'S LESIONS AND SOME VAGUE INFORMATION ABOUT THE POWER USED FOR THE TREATMENT (120W). PICTURES OF THE LESION WERE ALSO DISCLOSED. THE CLINICAL AFFAIRS MANAGER PERFORMED AN EVALUATION OF THE LESION REPORTED BY THE PATIENT AND CONCLUDED THAT THE BURN ARE A SECOND DEGREE THAT COULD REQUIRE MEDICAL ATTENTION IN ORDER TO PREVENT A PERMANENT IMPAIRMENT (BURNS ARE, ANYWAY, IDENTIFIED AS A FORESEEABLE SIDE EFFECT AS REPORTED ON THE OPERATOR'S MANUAL CODE OM116J1_G.V05 - ACTUAL DEVICE INVOLVED IN THE EVENT AT CHAPTER 11.3 "ADVERSE EFFECTS"). THE LESION HAS BEEN EVALUATED AS A SERIOUS INJURY BECAUSE THEY MAY REQUIRE MEDICAL ATTENTION TO PREVENT A PERMANENT IMPAIRMENT. BASED ON THE INFROMATION ABOVE WE, THE MANUFACTURER OF THE DEVICE, EVALUATED THE EVENT REPORTABLE TO THE US FDA IN ACCORDANCE WITH 21 CFR PART 803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322157 ONDA PRO ONDA PRPO PBX EL.EN. ELECTRONIC ENGINEERING S.P.A. M116J1 08034108511115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other