BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 11983595 · Received June 11, 2021

    Report

    Report Number
    1222993-2021-00017
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    December 1, 2020
    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 # MW5101110, CYNOSURE WAS UNABLE TO FURTHER INVESTIGATE THIS COMPLAINT. THERE WAS NO INFORMATION IDENTIFYING THE PATIENT, HEALTHCARE PROFESSIONAL OR ADDRESS OF THE LASER TREATMENT. 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 IS UNABLE TO DETERMINE WHETHER DIAGNOSES MADE POST TREATMENT WERE EXISTING PRIOR TO TREATMENT.

    Description of Event or Problem · 1

    MEDWATCH REPORT #MW5101110 WAS RECEIVED WITH REPORT THAT A PATIENT UNDERWENT A MONALISA TOUCH TREATMENT AND EXPERIENCED SEVERE PAIN WITH URINATION, PAINFUL URGE TO URINATE, AND SEVERE PAIN IN THE VULVA FOLLOWING A MONALISA TOUCH TREATMENT. PATIENT WAS PRESCRIBED ANTIBIOTICS AND ANTI-FUNGAL CREAM PRIOR TO SEEING A GYNECOLOGIST. AFTER MEETING WITH A GYNECOLOGIST, PATIENT WAS DIAGNOSED WITH LICHEN SCLEROSIS AND WAS PRESCRIBED CLOBETASOL PROPIONATE. PATIENT THEN SAW A UROGYNECOLOGIST WHO PRESCRIBED MYRBETRIC 25 MG PER DAY. PATIENT IS CURRENTLY SEEING A PELVIC FLOOR PHYSICAL THERAPIST. A BIOPSY WAS ALSO PERFORMED WITH PHYSICIAN CONFIRMING IT TO BE BENIGN. THE MAYO CLINIC STATES, "THE CAUSE OF LICHEN SCLEROSIS IS UNKNOWN. AN OVERACTIVE IMMUNE SYSTEM OR AN IMBALANCE OF HORMONES MAY PLAY A ROLE. PREVIOUS SKIN DAMAGE AT A PARTICULAR SITE ON YOUR SKIN MAY INCREASE THE LIKELIHOOD OF LICHEN SCLEROSIS AT THAT LOCATION." PATIENT REPORTS THAT SEX IS TOO PAINFUL, PAINFUL URINARY RETENTION AND A GREATER RISK OF SQUAMOUS CELL CARCINOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883368 N/A N/A GEX EL. EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ANTI-FUNGAL CREAM| ANTIBIOTICS| CLOBETASOL PROPIONATE| ESTRACE| MULTIVITAMIN| MYRBETRIC| VITAMIN B| VITAMIN D