BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1062912 · Received June 19, 2008

    Report

    Report Number
    3005099803-2008-00796
    Event Type
    Injury
    Date Received
    June 19, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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

    NOTE: DATE OF EVENT IS UNK. IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A PROCEDURE USING A PROLIEVE THERMODILITATION KIT TO TREAT BENIGN PROSTATIC HYPERPLASIA (BPH) OCCURRED ON A MALE PATIENT. ACCORDING TO THE COMPLAINANT, THE RECTAL TEMPERATURE MONITOR (RTM) WAS PLACED CORRECTLY, HOWEVER, DURING THE PROCEDURE, THE PATIENT COMPLAINED OF EXTREME RECTAL PAIN. THE PAIN WAS NOT THERMAL BUT DESCRIBED AS "DISCOMFORT". THE PROCEDURE WAS ABORTED AND ONCE THE RTM WAS REMOVED, THE PATIENT HAD "INSTANT RELIEF". THE PATIENT SENT HOME WITH A FOLEY CATHETER (UNKNOWN MANUFACTURER). ACCORDING TO THE COMPLAINANT, THE PATIENT DID NOT SUFFER ANY BURNS. REPORTEDLY, THE FOLEY CATHETER WAS REMOVED DURING THE FOLLOW-UP VISIT (DATE UNK) AND THE PATIENT'S CONDITION WAS REPORTED AS "FINE".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other