BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER TEMPERATURE SENSOR

    MDR report key: 923240 · Received September 19, 2007

    Report

    Report Number
    1221261-2007-00044
    Event Type
    Injury
    Date Received
    September 19, 2007
    Report Date
    August 20, 2007
    Manufacturer
    MRI MEDICAL INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES THEY TRIED TO INSERT THE FOLEY CATHETER INTO THE PT TWICE. THE BALLOON BURST SPONTANEOUSLY UPON INSERTION/INFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLEY CATHETER TEMPERATURE SENSOR 78GU CATHETER UROLOGICAL KOD MRI MEDICAL INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention