BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHNOMED

    MDR report key: 243838 · Received October 6, 1999

    Report

    Report Number
    243838
    Event Type
    Malfunction
    Date Received
    October 6, 1999
    Date of Event
    August 20, 1999
    Report Date
    October 5, 1999
    Manufacturer
    EDAP TECHNOMED, INC.
    Product Code
    MEQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROSTAPROBE LEAKED DURING PROSTATRON PROCEDURE. PROCEDURE ABORTED. DELAY IN OPERATING ROOM CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECHNOMED PROSTAPROBE MEQ EDAP TECHNOMED, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other