BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 11739286 · Received April 28, 2021

    Report

    Report Number
    1222993-2021-00010
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    July 1, 2013
    Report Date
    April 28, 2021
    Manufacturer
    EL. EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE PATIENT, BUT NONE WAS PROVIDED DESPITE MULTIPLE REQUESTS FROM CLINICAL. THEREFORE, CYNOSURE IS UNABLE TO DETERMINE THE DEVICE INFORMATION SUCH AS A SERIAL NUMBER TO FURTHER INVESTIGATE THIS COMPLAINT OR PERFORM A DEVICE ANALYSIS. CYNOSURE ALSO CANNOT DETERMINE THE DEVICE USED BASED ON THE MEDWATCH REPORT. CYNOSURE IS REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION AND BASED ON THE INFORMATION IN THE MEDWATCH REPORT STATING THE PATIENT EXPERIENCED ADVERSE EFFECTS AND SOUGHT MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    MEDWATCH REPORT #MW5099296 WAS RECEIVED WITH REPORT THAT A PATIENT UNDERWENT A MONALISA TOUCH TREATMENT AND EXPERIENCED PAIN AND BLADDER INFECTIONS. THE PATIENT WAS SEEN BY A UROLOGIST WHO DETERMINED THE PATIENT DOES NOT HAVE ANY MORE LINING IN HER BLADDER. PATIENT STATES TO HAVE BLADDER INFECTIONS INCLUDING A RESISTANT BACTERIA AND CAN NO LONGER HAVE INTERCOURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633317 N/A GEX EL. EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other