BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOT

    MDR report key: 1565548 · Received December 15, 2009

    Report

    Report Number
    3002591507-2009-00001
    Event Type
    Injury
    Date Received
    December 15, 2009
    Date of Event
    October 15, 2009
    Report Date
    December 14, 2009
    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. ACCORDING TO COMPLAINT TO (B) (6) BY DR (B) (6), (B) (6) UROLOGY GROUP. CORETHERM TREATMENT OF BPH WAS PERFORMED (B) (6) 2009. ON (B) (6), THE PT PRESENTED TO THE (B) (6) EMERGENCY ROOM WITH A CREATININE OF 8.05. RENAL SONOGRAPHY SHOWED BILATERAL HYDRONEPHROSIS. CYSTOSCOPY SHOWED AN OPEN PROSTATE WITH NECROSIS OF THE LUMEN BUT ALSO THERMAL INJURY TO THE BLADDER, AND IN PARTICULAR THE TRIGONE, WITH INJURY TO THE URETERAL ORIFICES ON BOTH SIDES.

    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 82 YR Required Intervention