BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 11769196 · Received May 4, 2021

    Report

    Report Number
    3001431138-2021-00004
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    July 1, 2013
    Report Date
    May 4, 2021
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K133895
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE, THE MANUFACTURER OF THE DEVICE, AND OUR US IMPORTER WERE UNABLE TO INVESTIGATE ANY FURTHER DUE TO THE FACT THAT THE PATIENT, DESPITE SEVERAL ATTEMPTS TO CONTACT HER (AS A GOOD FAITHFUL EFFORT), WAS UNRESPONSIVE. THEREFORE WE WERE UNABLE TO IDENTIFY THE DETAILS OF THE ACTUAL DEVICE INVOLVED IN THE EVENT (SUCH AS, BUT NOT LIMITED TO NAME OF THE DEVICE, MODEL NUMBER, SERIAL NUMBER, ETC.) OR THE CLINIC WHERE THE EVENT TOOK PLACE (SUCH AS, BUT NOT LIMITED TO NAME OF THE CLINIC, ADDRESS, PHYSICIAN NAME, ETC.). BASED ON THAT AND THE FACT THAT NO OTHER DETAILS REGARDING THE TREATMENT HAS BEEN DISCLOSED, ANY FURTHER INVESTIGATION RESULTED IMPOSSIBLE. THAT SAID, NO CONCLUSION HAS BEEN POSSIBLE TO BE MADE. 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 · 1

    ON APRIL THE 5TH, 2021, EL.EN. ELECTRONIC ENGINEERING (B)(4) BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY US AGENT (B)(6), THAT RECEIVED A COMMUNICATION FROM THE FDA, CONCERNING AN ADVERSE EVENT HAPPENED TO A PATIENT RECORDED ON THE MEDWATCH SYSTEM. THE PATIENT REPORTED TO THE FDA (MEDWATCH REPORT #MW5099296), ON (B)(6) 2021 AN ADVERSE EVENT HAPPENED TO HER, FOLLOWING MONALISA TOUCH TREATMENT PERFORMED IN DATE (B)(6) 2013. THE ACTUAL MEDICAL DEVICE INVOLVED IN THIS EVENT WAS NOT IDENTIFIED BY THE PATIENT IN THE MEDWATCH REPORT. MOREOVER THE PATIENT SUPPLIED HER GENERALITIES AND CONTACT INFORMATION ON THE MW5099296 REPORT. THE PATIENT REPORTED TO HAVE UNDERWENT THE TREATMENT, AS SUGGESTED BY HER GYNECOLOGIST, IN ORDER TO HELP PREVENT UTI'S AND PREVENT COMMON ISSUES FOR WOMEN OF HER AGE. FOLLOWING THE TREATMENT THE PATIENT COMPLAINT TO HAVE SEVERE BLADDER PAIN AND BLADDER INFECTIONS INCLUDING A RESISTANT BACTERIA. THE PATIENT ALSO STATED THAT HER UROLOGIST PERFORMED A CUSTOM ON HER AND THAT THERE IS NO LINING LEFT IN HER BLADDER WHICH IS NOW VERY IRRITATED. FINALLY THE PATIENT STATED THAT SHE CAN NO LONGER HAVE ANY SEXUAL INTERCOURSE. THE PATIENT DID NOT REPORT ANY INFORMATION RELATIVE TO THE DEVICE INVOLVED IN THE EVENT. ANYWAY THE ONLY TWO DEVICES THAT CAN PERFORM THE MONALISA TOUCH TREATMENT ARE THE SMARTXIDE2 AND SMARTXIDE TOUCH AND BOTH ARE MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING (B)(4) AND MARKETED IN THE UNITED STATES WITH 510(K) NUMBER K133895. WE, THE MANUFACTURER OF THE DEVICE, REQUESTED THE COOPERATION OF OUR US IMPORTER (B)(4), FOR THE INVESTIGATION ON THIS CASE. (B)(4) INFORMED THE MANUFACTURER IN DATE APRIL THE 6TH, 2021 THAT THEY HAVE ALREADY STARTED THEIR INVESTIGATION. (B)(4) ALSO REPRESENTS US DISTRIBUTOR AND SERVICE CENTER FOR EL.EN. ELECTRONIC ENGINEERING (B)(4) MEDICAL DEVICES. (B)(4). EVALUATED THE EVENT AS REPORTABLE BECAUSE THEY ASSUMED THE LESIONS TO BE A SERIOUS INJURY (ON THE SIDE OF CAUTION) AND SUBMITTED ITS OWN MDR REPORT #MDR-1222993-2021-00010 IN DATE APRIL THE 28TH, 2021 AS IMPORTER OF THE DEVICE. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON APRIL THE 5TH, 2021 BY EMAIL FROM THE US IMPORTER AND, ACCORDING TO 21 CFR PART 803.50(2), SUBMITTED TO FDA AN OWN MDR REPORT IN ORDER TO SUBMIT ADDITIONAL INFORMATION FORM THE REPORT SUBMITTED BY THE US IMPORTER. MOREOVER, WE EVALUATED THE EVENT REPORTABLE BECAUSE WE HAVE ASSUMED THE LESIONS TO BE A SERIOUS INJURY (ON THE SIDE OF CAUTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669195 UNKNOWN UNKNOWN GEX EL.EN. ELECTRONIC ENGINEERING S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other