BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNONW

    MDR report key: 7946198 · Received October 9, 2018

    Report

    Report Number
    3001431138-2018-00006
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    May 29, 2018
    Report Date
    October 9, 2018
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K133895
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE INVESTIGATE FURTHER INTO THE EVENT OF MEDWATCH REPORT #MW5079321 BECAUSE THERE IS NO INFORMATION IDENTIFYING THE PATIENT, HEALTHCARE PROFESSIONAL, OR ADDRESS OF THE LASER TREATMENT. THERE IS NO INFORMATION REGARDING THE PATIENT'S NAME, HEALTHCARE PROFESSIONAL'S NAME, OR ANY RELEVANT CONTACT INFORMATION. THE REPORT DOES NOT LIST A TELEPHONE NUMBER OR EMAIL ADDRESS TO CONTACT THE PATIENT OR HEALTHCARE PROFESSIONAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE EXACT DEVICE DETAILS SUCH AS SERIAL NUMBER AND REF NUMBER INVOLVED IN THIS EVENT. SINCE WE ARE UNABLE TO CONFIRM / OBTAIN ADDITIONAL INFORMATION ABOUT THIS EVENT, WE CAN ONLY RELY ON THE RELEVANT DETAILS LISTED IN THE #MW5079321 REPORT TO FORM AN EVALUATION. WITH THE LIMITED INFORMATION PER #MW5079321, WE CONSIDER THE DEVICE WAS UTILIZED PER ITS INTENDED USE, SPECIFICALLY FOR THE INCISION, EXCISION, ABLATION, VAPORIZATION AND COAGULATION OF BODY SOFT TISSUES IN GYNECOLOGY. WE BELIEVE THAT MOST LIKELY THE EVENT MIGHT HAVE BEEN CAUSED BY USER ERROR BECAUSE THE OPERATOR (GYNECOLOGIST) MAY HAVE WRONGLY TAKEN INTO CONSIDERATION THE PATIENT'S PRE-EXISTING HEALTH CONDITION. THE DEVICE ABLE TO PERFORM THE MONALISA TOUCH TREATMENT IS MARKETED IN THE US UNDER 510(K) K133895. WITHOUT A MODEL NUMBER, SERIAL NUMBER, OR CONTACT INFORMATION, WE ARE UNABLE TO PERFORM A DEVICE EVALUATION OR PROVIDE FURTHER INFORMATION REGARDING THE DEVICE INVOLVED. IMPOSSIBLE TO DETERMINE THE DEVICE INVOLVED AND TO CONFRIM / OBTAIN ADDITIONAL INFORMATION ON THIS EVENT. NO REMEDIAL ACTION REQUIRED. IN CASE OF NEW INFORMATION WILL BE MADE AVAILABE 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 · 1

    ON (B)(6) 2018, EL.EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY (B)(4) THAT RECEIVED A COMMUNICATION FROM THE FDA, CONCERNING AN ADVERSE EVENT HAPPENED TO A PATIENT RECORDED ON THE MEDWATCH SYSTEM WITH REPORT #MW5079321. THE PATIENT REPORTED TO THE FDA (MEDWATCH REPORT #MW5079321), ON (B)(6) 2018, AN ADVERSE EVENT HAPPENED TO HER, FOLLOWING A MONALISA TOUCH TREATMENT PERFORMED BY HER GYNECOLOGIST IN DATE (B)(6) 2018. THE ACTUAL MEDICAL DEVICE INVOLVED IN THIS EVENT IS UNKNOWN BECAUSE THERE IS NO INFORMATION IDENTIFYING THE PATIENT, HEALTHCARE PROFESSIONAL, OR ADDRESS OF THE LASER TREATMENT. THERE IS NO INFORMATION REGARDING THE PATIENT'S NAME, HEALTHCARE PROFESSIONAL'S NAME, OR ANY RELEVANT CONTACT INFORMATION. THE REPORT DOES NOT LIST A TELEPHONE NUMBER OR EMAIL ADDRESS TO CONTACT THE PATIENT OR HEALTHCARE PROFESSIONAL. ANYWAY THE DEVICE THAT COULD PERFORM SUCH TREATMENT ARE MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA AND MARKETED IN THE UNITED STATES WITH 510(K) NUMBER K133895. THE PATIENT REPORTED IN THE VOLUNTARY MEDWATCH REPORT #MW50779321 THAT SHE IS IN HER EARLY (B)(6) AND WAS SUFFERING FROM LICHEN SCLEROSUS. HER GYNECOLOGIST HAVE TREATED HER WITH MONALISA TOUCH IN ORDER TO GET HER CONDITIONS UNDER CONTROL. THE GYNECOLOGIST HAVE APPLIED EMLA GEL (ANESTHETIC) PRIOR TO THE TREATMENT IN ORDER TO NUMB THE AREA. ANYWAY, DUE TO THE NARROWNESS OF THE PATIENT'S VAGINAL CANAL, THE PATIENT SUFFERED A STRONG PAIN. IN ORDER TO ADDRESS THE PAIN THE GYNECOLOGIST INJECTED ANESTHETICS TO THE PATIENT THAT RESULTED, ANYWAY, INEFFECTIVE. FOLLOWING THE TREATMENT THE PATIENT REPORTED TO BE SUFFERING BURNS ON THE VULVA, BLADDER INFECTION, SWELLING THE VAGINAL AREA AND PAIN. (B)(4) (US IMPORTER) DUE TO THE LACK OF INFORMATION REPORTED IN THE MW5079321 RELATIVE TO PATIENT'S CONTACT INFORMATION, INFROMATION RELATED TO THE NAME AND PLACE OF THE CLINIC WAS UNABLE TO INVESTIGATE ANY FURTHER ON THIS CASE. ANYWAY, (B)(4). COMPANY LOCATED IN (B)(4) SUBMITTED AN MDR INITIAL REPORT TO FDA FOR THIS EVENT (#1222993-2018-00020) ON SEPTEMBER THE 21ST, 2018. (B)(4) 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 (B)(6), 2018 BY EMAIL FROM THE US IMPORTER AND, ACCORDING TO 21 CFR PART 803.50(B)(2), SUBMITTED TO FDA AN OWN MDR REPORT IN ORDER TO CONDUCT AN INVESTIGATION OF THE EVENT AND TO OBTAIN MISSING OR INCOMPLETE INFORMATION PROVIDED BY THE IMPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787476 UNKNONW UNKNOWN GEX EL.EN. ELECTRONIC ENGINEERING S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other