BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOT

    MDR report key: 1050356 · Received May 27, 2008

    Report

    Report Number
    3002591507-2008-00003
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    November 30, 2006
    Report Date
    May 20, 2008
    Manufacturer
    PROSTALUND OPERATIONS AB
    Product Code
    MEQ
    PMA / PMN Number
    P010055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT. ONE PT TREATED WITH PROSTALUND'S CORETHERM EQUIPMENT IN 2006 FOR TREATMENT OF BENIGN PROSTATIC HYPERPLASIA HAS LATER DEVELOPED INCONTINENCE. THIS REPORT RECEIVED IN CONNECTION WITH FOLLOW-UP OF TWO OTHER PTS FROM SAME CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOT 78MEQ MEQ PROSTALUND OPERATIONS AB PL CORETHERM

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention