BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 7899162 · Received September 21, 2018

    Report

    Report Number
    1222993-2018-00020
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    May 29, 2018
    Report Date
    September 21, 2018
    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 THE MEDWATCH REPORT #MW5079321, PATIENT EXPERIENCED SWELLING/PAIN/BURN FOLLOWING THE LASER PROCEDURE. THE PATIENT HAS LICHEN SCLEROSUS AND RECEIVED AN ANESTHETIC LOCAL INJECTION TO ADDRESS THE PAIN. HOWEVER, WE ARE UNABLE INVESTIGATE FURTHER INTO THE EVENT OF MEDWATCH REPORT #MW5079321 BECAUSE THERE IS NO INFORMATION IDENTIFYING THE PATIENT, HEALTHCARE PROFESSIONAL, OR ADDRESS OF THE LASER TREATMENT. THERE IS NO INFORMATION REGARDING THE PATIENT'S NAME, HEALTHCARE PROFESSIONAL'S NAME, OR ANY RELEVANT CONTACT INFORMATION. THE REPORT DOES NOT LIST A TELEPHONE NUMBER OR EMAIL ADDRESS TO CONTACT THE PATIENT OR HEALTHCARE PROFESSIONAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE EXACT DEVICE DETAILS SUCH AS SERIAL NUMBER AND CATALOG NUMBER INVOLVED IN THIS EVENT. SINCE WE ARE UNABLE TO CONFIRM / OBTAIN ADDITIONAL INFORMATION ABOUT THIS EVENT, CYNOSURE CAN ONLY RELY ON THE RELEVANT DETAILS LISTED IN THE #MW5079321 REPORT TO FORM AN EVALUATION. WITH THE LIMITED INFORMATION PER #MW5079321, WE CONSIDER THE DEVICE WAS UTILIZED PER ITS INTENDED USE, SPECIFICALLY FOR THE INCISION, EXCISION, ABLATION, VAPORIZATION AND COAGULATION OF BODY SOFT TISSUES IN GYNECOLOGY. WE BELIEVE THAT MOST LIKELY THE EVENT MIGHT HAVE BEEN CAUSED BY USER ERROR BECAUSE THE OPERATOR (GYNECOLOGIST) MAY HAVE WRONGLY TAKEN INTO CONSIDERATION THE PATIENT'S PRE-EXISTING HEALTH CONDITION. THE DEVICE IS MARKETED IN THE US UNDER 510(K) K133895. WITHOUT A MODEL NUMBER, SERIAL NUMBER, OR CONTACT INFORMATION, WE ARE UNABLE TO PERFORM A DEVICE EVALUATION OR PROVIDE FURTHER INFORMATION REGARDING THE DEVICE INVOLVED. IN RESPONSE TO THE PATIENT'S EXPERIENCE AND INTERVENTION OF A LOCAL ANESTHETIC INJECTION PER MW5079321, THIS IS A REPORTABLE EVENT.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED DISCOMFORT AND PAIN FOLLOWING A LASER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739111 N/A N/A GEX EL. EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other