BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIEVE THERMODILATATION KIT

    MDR report key: 1242934 · Received November 21, 2008

    Report

    Report Number
    3005099803-2008-06699
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A PROLIEVE THERMODILATATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE TWO DAYS PRIOR. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE, THE PATIENT EXPERIENCED HEMATURIA, NOTED TO BE "MILD" IN INTENSITY WITH THE EVENT ON-GOING. THE PATIENT ALSO EXPERIENCED A "BURNING SENSATION WHEN URINATING". THE INTENSITY TERMED TO BE "MILD" WITH THE EVENT ON-GOING. THE PATIENT'S CONDITION WAS REPORTED AS "ON-GOING". IT IS UNKNOWN IF INTERVENTION WAS REQUIRED OR GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILATATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 0000607021

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other