BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOT

    MDR report key: 841836 · Received April 23, 2007

    Report

    Report Number
    3002591507-2007-00001
    Event Type
    Injury
    Date Received
    April 23, 2007
    Report Date
    April 16, 2007
    Manufacturer
    PROSTALUND OPERATIONS AB
    Product Code
    MEQ
    PMA / PMN Number
    P010055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT. DURING FOLLOW-UP OF THE LAST SIX PATIENTS TREATED WITH PROSTALUND'S CORETHERM EQUIPMENT FOR TREATMENT OF BENIGN PROSTATIC HYPERPLASIA, DR. AT HOSP REPORTED, THAT FIVE OF THESE PTS HAVE URETHRA STRICTURES AND POSSIBLY TWO OF THEM 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 BOTH ON THE EQUIPMENT AND PATIENT DATA. PROSTALUND HAS CONTACTED THE HOSP FOR A MEETING (WITHIN 14 DAYS) TO REVIEW THE DATA. AT THE MEETING OUR CLINICAL EXPERT WILL PARTICIPATE. FOLLOW-UP REPORT INCLUDING TECHNICAL AND MEDICAL ANALYSIS BY OUR MEDICAL EXPERT IS PLANNED TO BE AVAILABLE BEFORE THE END OF MAY (MAY 31). REPORTS REGARDING THESE EVENTS HAVE ALSO BEEN SENT TO APPROPRIATE AUTHORITIES IN ANOTHER COUNTRY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention