BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE WITH DOT SCANNER

    MDR report key: 18132959 · Received November 14, 2023

    Report

    Report Number
    3001431138-2023-00011
    Event Type
    Injury
    Date Received
    November 14, 2023
    Date of Event
    November 26, 2022
    Report Date
    November 14, 2023
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    UDI-DI
    08057017760078
    PMA / PMN Number
    K072159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE, THE MANUFACTURER OF THE DEVICE PERFORMED THE INVESTIGATION BY CONTACTING THE CLINIC AND THE PHYSICIAN WHO PERFORMED THE TREATMENT ON THE PATIENT. WE CONTACTED THE CLINIC WHERE THE TREATMENT WAS PERFORMED AND THE ACTUAL DEVICE INVOLVED IN THE EVENT. IN FACT, THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS BEEN IDENTIFIED AS A DEKA SMARTXIDE WITH DOT SCANNER WITH SERIAL NUMBER (B)(6) THAT IS MARKETED IN THE US WITH 510(K) NUMBER K072159. WE REQUESTED MORE DETAILED INFORMATION TO THE PHYSICIAN OF THE CLINIC WHO PERFORMED THE TREATMENT, DR. (B)(6), WHO STATED TO HAVE NOT HEARD ANYTHING FROM THE PATIENT EVER SINCE THE TREATMENT AND TO NOT BEING AWARE OF ANY COMPLAINT FROM HER. NO MORE INFORMATION ABOUT THE VENT HAVE BEEN DISCLOSED FROM THE PHYSICIAN. THE EVENT TOOK PLACE AT (B)(6) CLINIC PLACED AT (B)(6) - USA.. THE ACTUAL DEVICE INVOLVED IN THE EVENT, HAS NOT BEEN CHECKED DUE TO THE FACT THAT ALMOST A YEAR HAS PASSED SINCE THE DATE OF THE EVENT (AS REPORTED BY THE PATIENT ON HER COMMUNICATION) AND BECAUSE THE USER NEVER REPORTED OF DEVICE'S FAILURES AND/OR ALARM THAT AROSE IN THIS YEAR. THE USER KEPT USING THE DEVICE NORMALLY WITHOUT ANY ISSUE. NO REMEDIAL ACTION REQUIRED - INVESTIGATION ON THE EVENT RESULTED IMPOSSIBLE, BASED ON THE AVAILABLE INFORMATION. ANYWAY, IN CASE OF NEW INFORMATION WILL BE MADE AVAILABLE FOR THIS CASE A FOLLOW-UP TO THIS REPORT WILL BE SUBMITTED IN A TIMELY MANNER. 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. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT VIA EMAIL FROM THE PATIENT IN WHICH SHE COMPLAINTS OF HYPOPIGMENTATION ON THE NECK AND FACE FOLLOWING A CO2 FRACTIONAL LASER TREATMENT. IN THE INITIAL COMMUNICATION RECEIVED FROM THE PATIENT IT IS NOT SPECIFIED THE ACTUAL MEDICAL DEVICE INVOLVED IN THE EVENT BUT THE PATIENT JUST SUPPOSED THAT THE DEVICE WAS A SMARTXIDE. PATIENT REPORTED THAT THE EVENT TOOK PLACE IN DATE (B)(6) 2022 AT (B)(6) IN (B)(6). BASED ON THE INFORMATION REPORTED ON THE PATIENT'S COMMUNICATION WE PROCEEDED BY CONTACTING THE CLINIC IN ORDER TO GATHER MORE DETAILED INFORMATION ON THE EVENT AND TO IDENTIFY THE ACTUAL DEVICE INVOLVED IN THE EVENT. THE DEVICE HAS BEEN IDENTIFIED AS A DEKA SMARTXIDE WITH DOT SCANNER (REF: M079R1 - S/N: (B)(6) - UDI: (B)(4) MANUFACTURED BY EL. EN. ELECTRONIC ENGINEERING SPA AD MARKETED IN THE USA WITH 510(K) NUMBER K072159. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON OCTOBER THE 18TH, 2023 BY EMAIL FROM THE PATIENT AND, ACCORDING TO 21 CFR PART 803 EVALUATED THE EVENT REPORTABLE BECAUSE WE HAVE ASSUMED THE LESIONS TO BE A PERMANENT IMPAIRMENT (ON THE SIDE OF CAUTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988919 DEKA SMARTXIDE WITH DOT SCANNER DEKA SMARTXIDE WITH DOT SCANNER GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M079R1 08057017760078

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other