BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE TEMPERATURE MONITOR

    MDR report key: 1172921 · Received September 19, 2008

    Report

    Report Number
    3005099803-2008-04736
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED, 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

    A PROLIEVE THERMODILITATION RECTAL TEMPERATURE MONITOR (RTM) WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURES IN 2008. ACCORDING TO THE COMPLAINANT, THE RTM WAS GIVING FAULTY READINGS AND THE TEMPERATURE DROPPED IN THE FIRST FIVE MINUTES OF THE PROCEDURE. THEN THE TEMPERATURE SPIKED UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER RTM DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE TEMPERATURE MONITOR MEQ BOSTON SCIENTIFIC CORPORATION M0068808030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK