BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 11983900 · Received June 11, 2021

    Report

    Report Number
    1222993-2021-00019
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    July 16, 2019
    Report Date
    June 11, 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

    BASED ON THE INFORMATION REPORTED IN MEDWATCH REPORT # MW5100533, CYNOSURE WAS UNABLE TO FURTHER INVESTIGATE THIS COMPLAINT. THERE WAS NO INFORMATION IDENTIFYING THE PATIENT, HEALTHCARE PROFESSIONAL, ADDRESS OF THE LASER TREATMENT OR WHAT THE DIAGNOSIS THE PATIENT RECEIVED WAS. THEREFORE, CYNOSURE IS UNABLE TO DETERMINE THE DEVICE INFORMATION SUCH AS A SERIAL NUMBER TO FURTHER INVESTIGATE THIS COMPLAINT, INVESTIGATE TREATMENT METHODS USED OR PERFORM A DEVICE ANALYSIS. CYNOSURE IS REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION AND BASED ON THE INFORMATION IN THE MEDWATCH REPORT STATING THE PATIENT SUSTAINED A PERMANENT INJURY AND SOUGHT MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    MEDWATCH REPORT # MW5100533 WAS RECEIVED WITH REPORT THAT A PATIENT UNDERWENT A MONALISA TOUCH TREATMENT AND EXPERIENCED SEVERE PAIN, BURNING, AND NERVE PAIN FOLLOWING A MONALISA TOUCH TREATMENT. PATIENT SUSTAINED A PERMANENT DISABLING INJURY AND WAS DIAGNOSED WITH PADENAL NEURALGIA AND VULVODYNIA. PATIENT IS CURRENTLY IN PAIN MANAGEMENT DUE TO ONGOING PAIN AND BEING UNABLE TO PERFORM NORMAL DAY TO DAY ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881239 N/A N/A GEX EL. EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability