BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 21405093 · Received February 18, 2025

    Report

    Report Number
    1222993-2025-00004
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 1, 2023
    Report Date
    February 18, 2025
    Manufacturer
    EL. EN. ELECTRONIC ENGINEERING S.P.A
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CYNOSURE RECEIVED MEDWATCH REPORT # MW5164072 ON (B)(6) 2025 WITH PATIENT REPORTING SEVERE PAIN AT VAGINAL OPENING AND LEFT SIDE OF THEIR INTERNAL VAGINAL WALL FOLLOWING 3 MONALISA TOUCH LASER TREATMENTS. DEVICE DETAILS ARE UNKNOWN SINCE MEDWATCH REPORT DID NOT HAVE THIS INFORMATION. PATIENT OR CLINIC CONTACT INFORMATION WAS ALSO NOT INCLUDED AND THEREFORE NO ADDITIONAL INFORMATION WAS RETRIEVED. CYNOSURE IS REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION AND BASED ON THE MEDWATCH REPORT STATING THE EVENT IS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2572948 N/A N/A GEX EL. EN. ELECTRONIC ENGINEERING S.P.A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other