BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE2 LASER

    MDR report key: 7121207 · Received December 15, 2017

    Report

    Report Number
    1222993-2017-00050
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    August 23, 2017
    Report Date
    December 15, 2017
    Manufacturer
    EL. EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    PER NOTIFICATION BY FDA REPORT MW5083896, ADDITIONAL DETAILS WERE MADE AVAILABLE REGARDING THE PATIENT WHO HAD MEDICAL INTERVENTION. THE PATIENT, WHO IS SEEKING MEDICAL CARE FROM A UROLOGIST, NOW CLAIMS OF NERVE DAMAGE IN THE LASER TREATED AREA. THE TREATMENT CARE FOR THE PATIENT'S CONDITION INCLUDED A COMBINATION OF PRESCRIPTION AND OTC MEDICATIONS FOR PAIN MANAGEMENT (PAIN MEDICATIONS, OTC MEDICATION/VITAMINS, MEDICAL MARIJUANA), AND A NERVE BLOCK INJECTION BY THE UROLOGIST.

    Description of Event or Problem · 0

    PATIENT HAD SIGNIFICANT DISCOMFORT/BURNING SENSATION IN THE URETHRA AREA FOLLOWING A LASER PROCEDURE.

    Additional Manufacturer Narrative · 1

    PATIENT IN THIS INCIDENT HAD MEDICAL INTERVENTION FROM 2 UROLOGISTS FOLLOWING A FOURTH LASER PROCEDURE WITH THE DEVICE. PATIENT HAD EXPRESSED A BENEFICIAL/POSITIVE EXPERIENCE FROM PREVIOUS TREATMENTS. THE CUSTOMER SITE'S DOCTOR DID INDICATE THE PATIENT HAS A HISTORY OF CYSTITIS, LONG STANDING URETHRAL PAIN PRIOR TO THE LASER PROCEDURES, WAS ON NUMEROUS MEDICATIONS FOR +25 YEARS, AND WAS LOOKING FOR ALTERNATIVE URETHRA PAIN MANAGEMENT TREATMENTS. HOWEVER THE PATIENT DECLINED TO FOLLOW UP WITH THE CUSTOMER SITE, SO THERE IS NO ADDITIONAL INFORMATION REGARDING THE TREATMENT FROM THIS EVENT. THE DEVICE WAS EVALUATED AND OPERATED AS INTENDED WITHIN SPECIFICATION. THIS EVENT IS REPORTABLE BECAUSE THE PATIENT HAD MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    PATIENT HAD SIGNIFICANT DISCOMFORT/BURNING SENSATION IN THE URETHRA AREA FOLLOWING A LASER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901130 DEKA SMARTXIDE2 LASER DEKA SMARTXIDE2 LASER GEX EL. EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other