BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDAP ABLATHERM INTEGRATED IMAGING

    MDR report key: 6442255 · Received February 17, 2017

    Report

    Report Number
    MW5068716
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    December 15, 2016
    Report Date
    February 6, 2017
    Manufacturer
    EDAP TMS FRANCE SA
    Product Code
    PLP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MAN UNDERWENT PROSTATE HEMIABLATION WITH EDAP ABLATHERM FOR GLEASON 7 PROSTATE CANCER IN (B)(6) 2016. PATIENT EXPERIENCED 3 EPISODES OF URINARY RETENTION. HAD TO BE HOSPITALIZED ON TWO OCCASIONS. FIRST TIME FOR CLOT EVALUATION FROM HEMATURIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124620 EDAP ABLATHERM INTEGRATED IMAGING EDAP ABLATHERM INTEGRATED IMAGING PLP EDAP TMS FRANCE SA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization