BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOT

    MDR report key: 923044 · Received October 5, 2007

    Report

    Report Number
    3002591507-2007-00004
    Event Type
    Injury
    Date Received
    October 5, 2007
    Report Date
    September 28, 2007
    Manufacturer
    PROSTALUND OPERATIONS AB
    Product Code
    MEQ
    PMA / PMN Number
    P010055
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT. DURING FOLLOW-UP OF THREE PTS TREATED WITH PROSTALUND'S CORETHERM EQUIPMENT IN 2006 FOR TREATMENT OF BENIGN PROTATIC HYPERPLASIA, DR AT THE HOSPITAL, UROLOGY DEPT, REPORTED THESE PTS TO HAVE UTETHRA STRICTURES, MAYBE SFINCTER DAMAGE. DURING INITIAL REVIEW OF TREATMENT PRINTOUT REPORTS, NO UNUSUAL INFO WAS FOUND; HOWEVER, MORE INDEPTH REVIEW AND ASSESSMENT WILL HAVE TO BE PERFORMED. A MEETING HAS BEEN PLANNED WITH THE CLINIC TO REVIEW THE DATA. FOLLOW-UP REPORT INCLUDING TECHNICAL AND MEDICAL ANALYSIS BY OUR MEDICAL EXPERT IS PLANNED TO BE AVAILABLE BEFORE NOV. 15, 2007. THESE REPORTS SEEM SIMILAR TO THE ONES PREVIOUSLY REPORTED FROM THE SAME CLINIC AS MFR REPORT 3002591507-2007-00001 (INITIAL REPORT 4/16/2007 AND FOLLOW-UP 5/30/2007. THE CLINIC HAS REPORTED THAT NO MORE TREATMENTS WITH CORETHERM EQUIPMENT HAS TAKEN PLACE AT THE CLINIC SINCE 2007.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention