BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1150492 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04381
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 2, 2008
    Report Date
    August 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE PROLIEVE THERMODILITATION KIT IS NOT KNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CANNOT BE DETERMINED. THE LOT NUMBER REPORTED IS FOR THE PROLIEVE CATHETER WHICH IS PART OF THE PROLIEVE THREMODILITATION KIT. THE DEVICE HAS NOT BEEN RECEIVED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    ON AUGUST 8, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILITATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE IN 2008 (PATIENT AGE AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PROLIEVE TREATMENT WAS CONSIDERED SUCCESSFUL. POST PROCEDURE (TIMEFRAME UNKNOWN) THE PATIENT WENT TO THE ER FOR CATHETER INSERTION IN ORDER TO TREAT FULL URINARY RETENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 606598

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R