BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOT

    MDR report key: 982211 · Received January 22, 2008

    Report

    Report Number
    3002591507-2008-00001
    Event Type
    Injury
    Date Received
    January 22, 2008
    Date of Event
    October 5, 2007
    Report Date
    January 10, 2008
    Manufacturer
    PROSTALUND OPERATIONS AB
    Product Code
    MEQ
    PMA / PMN Number
    P010055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT. PATIENT HAS DEVELOPED RECTOURETHRAL FISTULA AFTER A CORETHERM TREATMENT THAT INVOLVED VERY HIGH TEMPERATURES.

    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 72 YR Required Intervention