BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE DOT

    MDR report key: 8869700 · Received August 7, 2019

    Report

    Report Number
    3001431138-2019-00010
    Event Type
    Injury
    Date Received
    August 7, 2019
    Date of Event
    February 1, 2019
    Report Date
    August 7, 2019
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K072159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE THE MANUFACTURER OF THE DEVICE PERFORMED THE INVESTIGATION BASED ON THE INFORMATION THAT HAVE BEEN SUPPLIED BY THE DISTRIBUTOR WITH THE SUPPORT OF OUR INTERNAL CLINICAL STAFF AND THE ADVICES OF EXTERNAL PHYSICIANS. OUR INTERNAL CLINICAL STAFF EVALUATED THE PARAMETERS USED TO TREAT THE PATIENT AND EVALUATED THEM, BASED ON GOOD LASER MEDICAL PROCEDURES, AS TOO MUCH AGGRESSIVE RELATED TO THE AREA TREATED AND THE INTENDED TREATMENT. THE CONCLUSION PERFORMED BY OUR INTERNAL CLINICAL STAFF HAS BEEN CONFIRMED BY EXTERNAL PHYSICIANS DR. (B)(6) AND DR. (B)(6): BOTH OF THEM AGREE THAT THE PARAMETERS WERE VERY AGGRESSIVE. MOREOVER THE DISTRIBUTOR INFORMED US THAT THE PATIENT HAVE BEEN TREATED ALSO WITH LED TRIWINGS FOLLOWING THE LASER TREATMENT. THE LED TRIWINGS IS A PHOTODYNAMIC TREATMENT PERFORMED WITH A DEVICE, NOT MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA, THAT HAVE BEEN EVALUATED BY OUR CLINICAL STAFF NOT APPROPRIATE FOLLOWING THE LASER TREATMENT. IN FACT THE PHOTODYNAMIC TREATMENT IS NOT RECOMMENDED FOLLOWING A LASER TREATMENT IN ORDER TO AVOID ANY SIDE EFFECT SUCH AS SKIN HYPO/HYPER PIGMENTATION AND INFLAMMATION. IN FACT IN THE OPERATOR'S MANUAL CODE OM079C1-L1-S1-T1_G.V22 (ACTUAL REVISION SHIPPED WITH THE DEVICE) AT CHAPTER 10 'CLINICAL ASPECT' IS RECOMMENDED TO AVOID ANY SUN/UV/INTENSE LIGHT EXPOSURE BEFORE AND AFTER THE TREATMENT IN ORDER TO AVOID ANY SIDE EFFECT. THE ACTUAL MEDICAL DEVICE INVOLVED IN THE EVENT HAS BEEN EVALUATED SEVERAL TIMES IN DATE: 1ST OF APRIL 2019, 14TH OF MAY 2019 AND 5TH JULY 2019 AND ALWAYS FOUND TO BE WORKING PROPERLY. BASED ON THE INFORMATION GATHERED DURING THE INVESTIGATION, WE THE MANUFACTURE OF THE DEVICE, CONCLUDED THAT THE EVENT HAS BEEN CAUSED BY A USER ERROR IN WHICH THE PHYSICIAN FAILED TO SET THE CORRECT PARAMETERS FRO THE TREATMENT, USING TOO MUCH AGGRESSIVE PARAMETERS, AND UNDERWENT THE PATIENT TO A PHOTODYNAMIC TREATMENT FOLLOWING THE LASER TREATMENT. THE DEVICE IS WORKING PROPERLY SO NO REMEDIAL ACTION IS REQUIRED. THE OPERATOR'S MANUAL AND THE RISK MANAGEMENT FILE HAVE BEEN EVALUATED AND FOUND ADEQUATE. THIS INITIAL REPORT IS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 1

    ON JULY THE 22TH 2019, EL. EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE (B)(6) DISTRIBUTOR, THAT RECEIVED A COMMUNICATION FROM THE CLINIC CONCERNING AN ADVERSE EVENT IN WHICH THE PHYSICIAN HAVE TREATED 3 PATIENTS IN DIFFERENT AREAS (FACE, ABDOMEN AND TIGHT) IN WHICH ALL THE THREE PATIENTS DEVELOPED SCARS FOLLOWING THE TREATMENT. THE PRESENT REPORT IS DEDICATED TO PATIENT #3 THAT HAVE BEEN TREATED ON THE ABDOMEN AND DEVELOPED MICROCHANS, DISCOLORATION AND SCARS. THE ACTUAL MEDICAL DEVICE INVOLVED IN THIS EVENT IS A DEKA SMARTXIDE DOT REF M079S1 THAT IS NOT MARKETED IN THE US. ANYWAY A SIMILAR MODEL OF SMARTXIDE DOT REF M079R1, MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA, IS MARKETED IN THE US WITH 510(K) K072159. THE (B)(6) DISTRIBUTOR REPORTED THAT THE PARAMETERS USED BY THE PHYSICIAN TO TREAT THE PATIENT ARE: POWER 10W, SPACING 350, DWELL TIME 350. THE DISTRIBUTOR FORWARDED TO US ALSO PICTURES OF THE PATIENT, TOOK IN DATE THE (B)(6) 2019, IN WHICH ARE PRESENT MICROCHANS, LITTLE SCARS AND A MILD DISCOLORATION AND INFORMED US THAT THE PATIENT UNDERWENT LED TRIWINGS TREATMENTS FOLLOWING THE LASER TREATMENT. CONCERNING THE DATE OF THE TREATMENT AND THE DATE OF THE PICTURE THE INFORMATION WE RECEIVED ONLY THE INFORMATION ABOUT THE MONTH IN WHICH THE TREATMENT AND PICTURE WERE TOOK. A CLINICAL EVALUATION OF THE IMAGES AND PARAMETERS HAVE BEEN PERFORMED BY OUR PRODUCT MANAGER FOR THE DERMATOLOGICAL AREA MR. (B)(6) THAT CONCLUDED THAT, THE PARAMETERS USED BY THE PHYSICIAN ARE TOO MUCH AGGRESSIVE. THIS CONCLUSION HAVE BEEN CONFIRMED ALSO BY TWO DIFFERENT, EXTERNAL, PHYSICIAN DR. (B)(6) ((B)(6) KEY OFFICER, (B)(6) LASER TASK FORCE, ADJUNCT PROFESSOR OF LASER AT (B)(6) UNIVERSITY OF (B)(6), IN CHARGE OF LASER CUTANEOUS COSMETIC & PLASTIC SURGERY UNIT AT (B)(6)) AND DR. (B)(6) (MEMBER OF (B)(6)SOCIETY OF DERMATOLOGY, PRESIDENT OF (B)(6) OF AESTHETIC PHYSICIANS, MEMBER OF THE (B)(6) SCIENTIFIC COMMITTEE OF AESTHETIC SURGEONS AND OPERATORS). THE EVENT TOOK PLACE AT (B)(6) PLACED AT (B)(6). WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON JULY 12TH, 2019 BY EMAIL FROM THE (B)(6) DISTRIBUTOR AND, ACCORDING TO 21 CFR PART 803, EVALUATED THIS EVENT AS REPORTABLE BECAUSE THE PATIENT REQUIRED MEDICAL INTERVENTION TO PREVENT A PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665652 DEKA SMARTXIDE DOT DEKA SMARTXIDE DOT GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M079S1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other