BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE IQ

    MDR report key: 19643525 · Received July 1, 2024

    Report

    Report Number
    3001431138-2024-00011
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 1, 2024
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    UDI-DI
    08034108510880
    PMA / PMN Number
    K193426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    WE AS MANUFACTURER OF THE DEVICE HAVE PERFORMED OUR OWN INVESTIGATION BASED ON THE INFORMATION GATHERED BY THE US IMPORTER FROM THE CLINIC. THE LESION REPORTED BY THE PATIENT HAS BEEN EVALUATED INITIALLY BY CYNOSURE'S CLINICAL AND CONCLUDED THAT THE ONLY AREA THAT REPORTED BURN IS IN THE PROXIMITY OF THE FASTENER THAT HELD THE VEIL CLOSED (USUALLY WORE BY THE PATIENT). THE FASTENER HAS PROBABLY STAINED THE SKIN OF THE PATIENT CAUSING AN AUGMENTED ABSORPTION OF ENERGY IN THAT AREA. OUR OWN CLINICAL DEPARTMENT ANALYZED THE AVAILABLE INFORMATION THOROUGHLY AND CONFIRMED THE INVESTIGATION PERFORMED BY THE US IMPORTER. MOREOVER, THEY ADDED THAT ALSO THE RUBBING OF THE FASTENER ON THE PATIENT'S SKIN, FOLLOWING THE TREATMENT, COULD HAVE CONTRIBUTED TO THE WORSENING OF THE LESION. THE OPERATOR'S MANUAL CODE OM122A1-C1_G.V11 (ACTUAL REVISION SHIPPED WITH THE DEVICE) - AT CHAPTER 'TREATMENT RECOMMENDATIONS' - CLEARLY STATES THAT THE SKIN MUST BE THOROUGHLY CLEANSED, FROM ANY DEBRIS THAT CAN ABSORB THE LASER ENERGY, BEFORE THE TREATMENT. AS WELL, THE JUST MENTIONED OPERATOR'S MANUAL, ALSO STATES - AT CHAPTER 'POSTTREATMENT RECOMMENDATIONS - TO DO NOT RUB AND/OR SCRATCH THE TREATED AREA. AT LAST, BURNS AND SCARRING ARE IDENTIFIED AS A FORESEEABLE SIDE EFFECT IN THE OPERATOR'S MANUAL CODE OM122A1-C1_G.V11 (ACTUAL REVISION SHIPPED WITH THE DEVICE) IN SECTION "SIDE EFFECT". ANYWAY, WE EVALUATE, THIS EVENT AS A SERIOUS INCIDENT BECAUSE THE PATIENT WOULD REQUIRE MEDICAL ATTENTION TO PREVENT A PERMANENT IMPAIRMENT. BASED ON THAT IS POSSIBLE TO CONCLUDE THAT THE MOST PROBABLE CAUSE OF THE EVENT IS A USER ERROR WHERE THE PHYSICIAN FAILED TO PROPERLY CLEAN THE PATIENT'S SKIN BEFORE PERFORMING THE TREATMENT AND/OR TO INFORM THE PATIENT ABOUT THE PROPER POSTTREATMENT RECOMMENDATIONS. NO DESIGN DEFICIENCY HAS BEEN FOUND TO BE CONTRIBUTORY TO THE EVENT. NO CORRECTIVE ACTION/PREVENTIVE ACTION/FSCA IS REQUIRED. THE PRESENT INITIAL REPORT HAS TO BE CONSIDERED AS A FINAL REPORT UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 0

    ON JUNE THE 4TH, 2024, EL. EN. ELECTRONIC ENGINEERING SPA RECEIVED A COMMUNICATION FROM THE US IMPORTER (B)(6) OF AN ADVERSE EVENT FOLLOWING A TREATMENT WITH THE DEVICE ELITE IQ. TO BE NOTED THAT THE ACTUAL DEVICE INVOLVED IN THIS EVENT IS NOT THE EXACT MODEL MARKETED IN THE US( REF CODE OF THE ACTUAL DEVICE INVOVLED IN THE EVENT IS M122A1). ANYWAY A SIMILAR MODEL OF ELITE IQ (WITH REF: (B)(4)) IS MARKETED IN THE US WITH 510(K) NUMBER K193426. IN THE ABOVE-MENTIONED COMMUNICATION IS REPORTED THE FOLLOWING: (B)(6) REPORTED THAT THE PATIENT HAS BEEN TREATED FOR HAIR REMOVAL ON THE FACE AND NECK. FOLLOWING THE TREATMENT, A BURN ON THE CHIN AREA HAS BEEN REPORTED. THE PARAMETERS USED FOR THE TREATMENT WERE THE FOLLOWING: 12MM HANDPIECE, ND:YAG LASER SOURCE, 35J/CM2 FLUENCE, PULSE DURATION EQUAL TO 25MS. PICTURES OF PATIENT'S LESION HAS BEEN ALSO SHARED. THE EVENT TOOK PLACE IN DATE MAY THE 1ST, 2024 AT (B)(6) THE PRESENT ADVERSE EVENT HAS BEEN EVALUATED AS A REPORTABLE EVENT BECAUSE THE PATIENT WOULD REQUIRE MEDICAL ATTENTION FOLLOWING THE TREATMENT IN ORDER TO PREVENT A PERMANENT IMPAIRMENT (SCARS). MOREOVER, THE US IMPORTER, CYNOSURE, PROCEEDED TO SUBMIT THEIR OWN MDR REPORT CODE MDR1222993-2024-00030 IN DATE JUNE THE 20TH, 2024. WE THE MANUFACTURER OF THE DEVICE PROCEEDED TO SUBMIT OUR OWN MDR REPORT, IN ACCORDANCE WITH 21 CFR PART 803.50(2) IN ORDER TO SUPPLY ANY MISSING INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349525 ELITE IQ ELITE IQ GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M122A1 08034108510880

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other