BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE TEMPERATURE MONITOR

    MDR report key: 2150417 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02130
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 2, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THE DEVICE WAS MISSING THE PLASTIC GUIDE, PLASTIC SCREW AND SCROTAL GUARD; IN ADDITION, FLUID WAS OBSERVED INSIDE THE TEMPERATURE BULB. THE SCROTAL GUARD AND RING WERE NOT RETURNED. THE REPORTED COMPLAINT WAS CONFIRMED AS THE BROKEN SCROTAL GUARD AND RING WERE MISSING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE PERTINENT LOT WAS PERFORMED AND NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY SIMILAR COMPLAINTS REPORTED FOR THE SAME LOT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP, THAT A RECTAL TEMPERATURE MONITOR (RTM) WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE RING OF THE RECTAL TEMPERATURE MONITOR (RTM) WAS CRACKED. THE PROCEDURE WAS NOT COMPROMISED AND THE RTM WAS USED WITHOUT A SCROTUM PLATE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE TEMPERATURE MONITOR MEQ BOSTON SCIENTIFIC CORPORATION M0068808030 CEL0723352

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK