BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE IQ

    MDR report key: 14013249 · Received April 5, 2022

    Report

    Report Number
    3001431138-2022-00003
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    February 17, 2022
    Report Date
    April 5, 2022
    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 AS WELL AS THE PARAMETERS USED FOR THE TREATMENT HAS BEEN EVALUATED BY OUR MANAGER OF CLINICAL RESEARCH AND PRACTISE AND HIS CONCLUSIONS ARE THE FOLLOWING: THE MOST PROBABLE CAUSE OF THE EVENT IS DUE TO A SERIES OF USER ERRORS MADE BY THE PHYSICIAN: IN FACT IT IS EVIDENT, FROM THE PICTURES OF THE PATIENT THAT SHE HAS BEEN TREATED WITHOUT ANY SHAVING DONE PRIOR TO THE TREATMENT'S AREA. THIS CAUSED THE HAIR TO ABSORB ENERGY ON THE SURFACE OF THE SKIN CAUSING HEAT AND SUBSEQUENT MILD BURNS. SHAVING OF THE TREATMENT ARE IS REQUIRED ON THE OPERATOR'S MANUAL CODE (B)(4) (ACTUAL REVISION SHIPPED WITH THE DEVICE) AS A PRE-TREATMENT OPERATION. MOREOVER THE PATIENT SEEMS TO BE STILL TANNED AT THE BEGINNING OF THE TREATMENT'S CYCLE WHICH MADE THE TREATMENT WITH THE ALEX LASER SOURCE (755NM) CONTRAINDICATED. IN THE PICTURES TAKEN ON THE FOLLOWING TREATMENTS THE PATIENT SEEM TO HAVE THE AREA STILL INFLAMED, WHICH IS ALSO A CONTRAINDICATED CONDITION FOR THE TREATMENT. WHAT JUST MENTIONED IS PRESENT IN THE OPERATOR'S MANUAL CODE (B)(4) (ACTUAL REVISION SHIPPED WITH THE DEVICE) AT CHAPTER "CONTRAINDICATIONS". AS SPECIFIED IN THE DEVICE'S OPERATOR'S MANUAL CODE (B)(4) (ACTUAL REVISION SHIPPED WITH THE DEVICE) AT CHAPTER 'ADVERSE EFFECTS' BURNS, BLISTERS AND HYPOPIGMENTATION ARE A FORESEEABLE SIDE EFFECT. THE ACTUAL DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN EVALUATED BY CYNOSURE'S AUTHORIZED LOCAL TECHNICIAN BECAUSE THE CLINIC REFUSED TO GIVE THEM ACCESS TO INSPECT THE DEVICE INVOLVED IN THIS EVENT. 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 EVALUATE THE CORRECT PROCEDURES AND EVALUATIONS OF THE PATIENT PRIOR TO THE TREATMENT (SHAVING AND EVALUATION OF CONTRAINDICATED CONDITIONS). 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 (B)(6) 2022, EL. EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE US IMPORTER, CYNOSURE, IN WHICH IT IS STATED THAT A PATIENT DEVELOPED HYPOPIGMENTATION 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: (B)(4), S/N: (B)(4), UDI: (B)(4). THE ACTUAL DEVICE INVOLVED IN THE EVENT IS MANUFACTURED BY (B)(4) AND MARKETED IN THE US WITH 510(K) K193426. THE EVENT TOOK PLACE AT (B)(6) USA. IN THE NARRATIVE PROVIDED OF THE EVENT IT IS STATED THAT THE PATIENT WAS UNDERGOING THE FIFTH TREATMENT FOR HAIR REMOVAL ON THE ARM AREA. PREVIOUS TREATMENTS WERE PERFORMED SINCE (B)(6) 2021. THE PARAMETERS USED FOR THE LATEST TREATMENT, PERFORMED IN DATE (B)(6) 2022, ARE: 18MM HANDPIECE, 10J/CM2, 20MS WITH THE 755. NM LASER SOURCE (ALEX). THE PATIENT HAVE A TYPE SKIN III (FITZPATRICK SCALE). FOLLOWING THE TREATMENT THE PATIENT SEEK MEDICAL ATTENTION TO A PLASTIC SURGEON IN ORDER TO SOLVE THE HYPOPIGMENTATION. SHE WAS PRESCRIBED WITH GLYCOLIC 18% CREAM. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON (B)(6) 2022 BY SPECIFIC COMMUNICATION OF THE US IMPORTER, CYNOSURE, 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 CYNOSURE, ALREADY EVALUATED THE EVENT AS REPORTABLE (FOR THE SAME REASON) AND PROCEEDED TO SUBMIT THEIR OWN MDR REPORT CODE MDR 12222993-2022-00009 IN DATE (B)(6) 2022. 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
    95812 ELITE IQ ELITE IQ GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M122B1 08057017760450

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention