BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER TEMPERATURE SENSOR

    MDR report key: 1054020 · Received May 29, 2008

    Report

    Report Number
    1221261-2008-00024
    Event Type
    Injury
    Date Received
    May 29, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 1, 2008
    Manufacturer
    MRI MEDICAL INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL - OTHER: SMITHS MEDICAL INVESTIGATION INTO THIS EVENT IS VERY LIMITED AS THE USER FACILITY DID NOT RETAIN THE SAMPLE OR RECORD THE LOT NUMBER OR RESPOND TO OUR REQUEST FOR FURTHER DETAILS. WITHOUT THE SAMPLE, WE ARE UNABLE TO DETERMINE IF THIS EVENT IS DUE TO USER ERROR OR A DEVICE MALFUNCTION. IF WE RECEIVE FURTHER INFO, THEN, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    USER ALLEGES BALLOON BROKE. WHEN PULLED CATHETER OUT WAS NOT INTACT, MAY BE INSIDE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention