BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE TETRA

    MDR report key: 16741830 · Received April 14, 2023

    Report

    Report Number
    3001431138-2023-00003
    Event Type
    Injury
    Date Received
    April 14, 2023
    Date of Event
    March 27, 2023
    Report Date
    April 14, 2023
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    UDI-DI
    08057017760290
    PMA / PMN Number
    K180193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE, THE MANUFACTURER OF THE DEVICE PERFORMED THE INVESTIGATION BASED ON THE DATA GATHERED FROM THE CLINIC BY OUR US IMPORTER, CARTESSA AESTHETICS,. THE EVENTS HAS BEEN EVALUATED BY OUR CLINICAL, RESEARCH AND PRACTICE (CRP) DEPARTMENT'S DIRECTOR WHO CONCLUDED THAT THE PARAMETERS USED WERE TOO MUCH AGGRESSIVE (REDUCED SPACING) AND THE USE OF RETINOID DRUGS WAS INTERRUPTED TOO EARLY IN RELATION TO THE DATE OF TREATMENT (ONLY ONE WEEK PRIOR). IN FACT RETINOID DRUGS INCREASE THE PHOTOSENSITIVITY OF THE SKIN. POST TREATMENT CARE WAS PERFORMED ONLY WITH AESTHETIC OINTMENT. THE LESION ARE CONSIDERED TO BE FIRST DEGREE BURNS THAT, IF CORRECTLY TREATED, CANNOT LED TO PERMANENT IMPAIRMENT. THE LESIONS ARE ANYWAY CONSIDERED AS SERIOUS INJURIES ON THE SIDE OF CAUTION. THE ACTUAL DEVICE INVOLVED IN THESE EVENTS HAS BEEN EVALUATED, BY LOCAL AUTHORIZED SERVICE, IN DATE APRIL THE 6TH, 2023 AND FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS (SERVICE REPORT ID#: (B)(4). BASED ON WHAT STATED ABOVE IS POSSIBLE TO CONCLUDE THAT THE EVENT HAS BEEN CAUSED BY A USER ERROR WHERE THE PHYSICIAN USED TOO MUCH AGGRESSIVE PARAMETERS FOR THE TREATMENT AND DID NOT EVALUATED PROPERLY THE EXISTING CONDITION OF THE PATIENT BEFORE PERFORMING THE TREATMENT. NO DESIGN ISSUE NOR DEFICIENCY HAS BEEN IDENTIFIED AS CAUSE OF THE EVENT. THE RISK MANAGEMENT FILE OF THE DEVICE CODE RMF_M118XX_02 HAS BEEN EVALUATED FOR THE RISK RELATIVE TO LESION TO PATIENTS DUE TO USER ERROR AND FOUND STILL ADEQUATE. NO REMEDIAL ACTION REQUIRED - DEVICE IS WORKING PROPERLY WITHIN SPECIFICATIONS. THIS INITIAL REPORT IS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2023, EL. EN. ELECRTONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE US IMPORTER, CARTESSA AESTHETICS, IN WHICH THEY INFORMED US TO HAVE RECEIVED FROM A CLINIC A COMPLAINT IN WHICH IT IS REPORTED THAT 3 PATIENT DEVELOPED LESIONS ON THE FACE FOLLOWING A DERMATOLOGICAL TREATMENT WITH THE DEVICE SMARTXIDE TETRA. THE EVENTS TOOK PLACE ALL IN THE SAME CLINIC WITH THE SAME DEVICE. THE ACTUAL DEVICE INVOLVED IN THIS EVENT IS A DEKA SMARTXIDE TETRA MANUFACTURED BY EL.EN. SPA AND MARKETED IN THE US WITH 510(K) NUMBER K180193. ALL THE THREE PATIENT'S LESIONS AND TREATMENT HAS BEEN EVALUATED. THE FIRST TWO HAS BEEN CONSIDERED REPORTABLE, ON THE SIDE OF CAUTION, CONSIDERING THEIR LESION AS SERIOUS INJURIES (FIRST DEGREE BURNS). THE THIRD PATIENT'S LESION HAS BEEN EVALUATED TO NOT BE SERIOUS INJURIES THAT WOULD HEAL PROPERLY WITH STANDARD POST-TREATMENT CARE (EVALUATION PERFORMED BY A PERSON QUALIFIED TO MAKE A MEDICAL JUDGEMENT). THE PRESENT REPORT WILL COVER THE EVENT RELATIVE TO PATIENT A. PATIENT IS A FEMALE, 34 YEARS OLD WITH SKIN TYPE III (FITZPATRICK SCALE). THE DAY AFTER THE TREATMENT THE PATIENT REPORTED FEELING TENDER AND WARM, BUT 48 HOURS LATER, REPORTS SWELLING, ITCHINESS, FEELING LIKE SHE HAS HIVES AND WELTING IN SOME AREAS. THE TREATMENT WAS PERFORMED WITH THE FOLLOWING PARAMETERS: 4W/400 SPACING HP MODE, SMART TRACK, SPRAY MODE. IT IS REPORTED THAT THE END-POINT OF THE TREATMENT WAS MILD ERYTHEMA, NOTHING OUT OF ORDINARY, AND NO EDEMA. PATIENT WAS TOPICALLY NUMBED WITH BLT PRIOR TO TREATMENT, REPORTED NO DISCOMFORT OR EXCESSIVE HEAT SENSATION DURING TREATMENT. PATIENT DID NOT USE ANY RETINOLS ONE WEEK PRIOR. NOT ON ANY ANTIBIOTICS OR ANTICOAGULANTS. AS POST TREATMENT ON THE PATIENT: ELTA MD SILVER GEL AND DERMAL WOUND SPRAY WAS APPLIED IMMEDIATELY POST. THE FOLLOWING DAY, ANTEAGE BIOGEL, SKIN BETTER SCIENCE TONE COMPACT, CLEANSING GEL, AND TRIO MOISTURIZER WERE APPLIED. THE FOLLOWING DAY, STOPPED USING THE ANTEAGE, SWITCHED TO ANFISA'S HYDRABALM. WE, THE MANUFACTURER OF THE DEVICE, REQUESTED THE COOPERATION OF OUR US IMPORTER CARTESSA AESTHETICS COMPANY LOCATED IN MELVILLE,11747, NEW YORK FOR THE INVESTIGATION ON THIS CASE. CARTESSA AESTHETICS ALSO REPRESENTS US DISTRIBUTOR AND SERVICE CENTER FOR EL.EN. ELECTRONIC ENGINEERING SPA MEDICAL DEVICES. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON MARCH THE 31ST, 2023 BY EMAIL FROM THE US IMPORTER AND, ACCORDING TO 21 CFR PART 803 EVALUATED THE EVENT REPORTABLE BECAUSE WE HAVE ASSUMED THE LESIONS TO BE A SERIOUS INJURY (ON THE SIDE OF CAUTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305319 DEKA SMARTXIDE TETRA DEKA SMARTXIDE TETRA GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M118C1 08057017760290

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Other