BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOT

    MDR report key: 950797 · Received November 21, 2007

    Report

    Report Number
    3002591507-2007-00005
    Event Type
    Injury
    Date Received
    November 21, 2007
    Date of Event
    September 13, 2007
    Report Date
    November 16, 2007
    Manufacturer
    PROSTALUND OPERATIONS AB
    Product Code
    MEQ
    PMA / PMN Number
    P010055
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT. DURING FOLLOW-UP OF PATIENT TREATED WITH PROSTALUND CORETHERM SYSTEM, THE PATIENT COMPLAINED OF SLIGHT URINE LEAKAGE THRU THE RECTUM. COULD POSSIBLY BE A RECTAL FISTULA. THE PATIENT IS CURRENTLY CATHETERIZED AND WILL BE REEXAMINED IN THREE WEEKS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention