BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE IQ

    MDR report key: 13024474 · Received December 17, 2021

    Report

    Report Number
    3001431138-2021-00015
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    November 10, 2021
    Report Date
    December 17, 2021
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    UDI-DI
    08057017760450
    PMA / PMN Number
    K193426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE THE MANUFACTURER OF THE DEVICE PERFORMED OUR OWN INVESTIGATION, BASED ON THE DATA AND PICTURES DISCLOSED BY THE US IMPORTER WHICH ARE THE FOLLOWING: THE INFORMATION DISCLOSED RELATIVE TO THE PATIENT (PICTURES OF THE LESIONS) AS WELL AS THE PARAMETERS USED FOR THE TREATMENT HAS BEEN EVALUATED BY DR. (B)(6) ((B)(6) KEY OFFICER, EADV LASER TASK FORCE, ADJUNCT PROFESSOR OF LASER AT (B)(6), IN CHARGE OF LASER CUTANEOUS COSMETIC & PLASTIC SURGERY UNIT AT (B)(6) CLINIC (B)(6)) AND HIS CONCLUSIONS ARE THE FOLLOWING: THE MOST PROBABLE CAUSE OF THE EVENT IS DUE TO A USE OF TOO MUCH AGGRESSIVE PARAMETERS FOR THE TREATMENT (IN RELATION TO THE TREAT AREA AND PATIENT'S SKIN TYPE) AND A POSSIBLE OVERLAPPING OF THE SHOTS. THIS CAUSED THE DELIVERY OF TOO MUCH ENERGY TO THE PATIENT'S LIP, WHICH CAUSED THE BUILDUP OF EXCESSIVE HEAT (BRUISES) AND THE CONSEQUENT EDEMA. AS SPECIFIED IN THE DEVICE'S OPERATOR'S MANUAL CODE (B)(4) (ACTUAL REVISION SHIPPED WITH THE DEVICE) AT CHAPTER 'ADVERSE EFFECTS' EDEMA IS A FORESEEABLE SIDE EFFECT ESPECIALLY IN CASE OF USE OF EXCESSIVE ENERGY. THE ACTUAL DEVICE INVOLVED IN THIS EVENT HAS BEEN EVALUATED BY (B)(4) AUTHORIZED LOCAL TECHNICIAN IN DATE (B)(6) 2021 (SERVICE REPORT CODE (B)(4)) AND FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS WITHOUT ANY SERVICE INTERVENTION. THE INVESTIGATION CARRIED OUT DID NOT CONCLUDE THAT A DESIGN DEFICIENCY WAS RESPONSIBLE FOR CAUSING THE EVENT INSTEAD IS POSSIBLE TO CONCLUDE THAT THE EVENT HAS BEEN CAUSED BY A FAILURE OF THE OPERATOR TO PROPERLY PERFORM THE TREATMENT (OVERLAPPING) AND TO EVALUATE THE CORRECT PARAMETERS IN RELATION TO THE PATIENT'S CHARACTERISTICS (TOO MUCH AGGRESSIVE TREATMENT). DUE TO THE FACT THAT THE DEVICE IS WORKING PROPERLY WITHIN SPECIFICATIONS, NO CORRECTIVE ACTION HAS BEEN IMPLEMENTED. THE PRESENT INITIAL REPORT HAS TO BE CONSIDERED AS A FINAL REPORT UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 0

    ON DECEMBER THE 1ST 2021, EL. EN. ELECTRONIC ENGINEERING (B)(4) BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE US IMPORTER, CYNOSURE, IN WHICH IT IS STATED THAT A PATIENT DEVELOPED AN EDEMA ON THE UPPER LIP FOLLOWING A HAIR REMOVAL TREATMENT WITH THE ELITE IQ LASER MEDICAL DEVICE. THE ACTUAL DEVICE INVOLVED IN THE EVENT IS AN ELITE IQ LASER MEDICAL DEVICE REF: M122B1, S/N: (B)(4), UDI: (B)(4). THE ACTUAL DEVICE INVOLVED IN THE EVENT IS MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING (B)(4) AND MARKETED IN THE US WITH 510(K) K193426. THE EVENT TOOK PLACE AT (B)(6). BASED ON THE NARRATIVE PROVIDED BY THE US IMPORTER, (B)(4), THE PATIENT DEVELOPED AN EDEMA THAT AFFECTED THE WHOLE UPPER LIP. AS PER IMAGES OF THE EVENT THAT HAS BEEN DISCLOSED IS POSSIBLE TO NOTE A BRUISE ON THE LEFT SIDE OVER THE UPPER LIP. TREATMENT WAS PERFORMED WITH THE FOLLOWING PARAMETERS: 1064NM ND:YAG LASER SOURCE, 10 MM HANDPIECE, 20MS, 45 J/CM2. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON DECEMBER THE 1ST 2021 BY SPECIFIC COMMUNICATION OF THE US IMPORTER, (B)(4) AND EVALUATED THE EVENT REPORTABLE BECAUSE, ACCORDING TO FDA 21 CFR PART 803 THIS EVENT REPRESENT A SERIOUS INJURY DUE TO THE FACT THAT THE PATIENT RECEIVED MEDICAL ATTENTION FOLLOWING THE TREATMENT. MOREOVER, THE US IMPORTER (B)(4), ALREADY EVALUATED THE EVENT AS REPORTABLE (FOR THE SAME REASON) AND PROCEEDED TO SUBMIT THEIR OWN MDR REPORT CODE MDR 12222993-2021-00047 IN DATE DECEMBER THE 9TH, 2021. BASED ON THAT, IN ACCORDANCE TO 21 CFR PART 803.50(3), WE AS MANUFACTURER OF THE DEVICE PROCEEDED TO SUBMIT OUR OWN MDR REPORT IN ORDER TO SUBMIT ALL THE MISSING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929057 ELITE IQ ELITE IQ GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M122B1 08057017760450

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other