BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOT

    MDR report key: 1817049 · Received August 20, 2010

    Report

    Report Number
    3002591507-2010-00001
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    May 24, 2010
    Report Date
    August 20, 2010
    Manufacturer
    PROSTALUND OPERATIONS AB
    Product Code
    MEQ
    PMA / PMN Number
    P010055
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORT. THE PATIENT IS AN (B)(6) PREVIOUSLY HEALTHY MAN WHO IN (B)(6) 2010 DEVELOPED ACUTE URINARY RETENTION. THE PATIENT CONSULTED DR (B)(6) AT UROLOGCENTRUM IN (B)(6) ON (B)(6) 2010 THIS YEAR. CYSTOSCOPY WAS THEN PERFORMED. ON (B)(6) CORETHERM TREATMENT FOR HIS BPH WAS PERFORMED. ON (B)(6), THE PATIENT CAME FOR FOLLOW-UP AT UROLOGCENTRUM, AND IT WAS NOTED THAT THE PATIENT RECENTLY HAD LEFT (B)(6) HOSPITAL IN (B)(6) AFTER AN OPERATION FOR AN INFLAMED BLADDER DIVERTICULA. ONE CAN READ FROM THE JOURNAL FROM THE VISIT JUNE 16 THAT THE DIVERTICULA WAS LOCATED VENTRALLY AND THAT THE MICROWAVE TREATMENT CATHETER PROBABLY HAD BEEN PLACED IN THE DIVERTICULA AND THAT THE BALLOON FOR FIXATION THUS HAD BEEN INFLATED INSIDE THE DIVERTICULUM. THE TREATMENT SHOULD ACCORDINGLY BY ACCIDENT HAVE BEEN PERFORMED WITHIN THE DIVERTICULUM AND NOT AS INTENDED IN THE PROSTATIC URETHRA.

    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