BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN 14 FRENCH SILICONE COUDE FOLEY

    MDR report key: 18086476 · Received November 6, 2023

    Report

    Report Number
    MW5147867
    Event Type
    Injury
    Date Received
    November 6, 2023
    Date of Event
    October 28, 2023
    Report Date
    November 1, 2023
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON DECEMBER 21, 20023 FOR REPORT NUMBER MW5147867 TO CHANGE MANUFACTURER'S NAME. UNKNOWN HOW CATHETER FOUND NO LONGER IN PLACE. PATIENT WAS AWAKE, ALERT, ORIENTED. HE SAID HE HEARD POP. THIS WAS NOT WITNESSED.

    Description of Event or Problem · 0

    PATIENT IS A 60 YEAR OLD MALE WHO BROUGHT TO ED(EMERGENCY DEPARTMENT) FOR INCOMPLETE BLADDER EMPTYING (LARGE HYDROCELE) WITH FAILED CATHETER ATTEMPTS. HE HAD A COUTE FOLEY PLACED WITH NO INJURY WHERE LATER IT WAS NO LONGER IN PLACE WITH RETENTION OF CATHETER TIP CONFIRMED ON CT REQUIRING SURGICAL REMOVAL. UNKNOWN HOW CATHETER FOUND NO LONGER IN PLACE. PATIENT WAS AWAKE, ALERT, ORIENTED. HE SAID HE HEARD POP. THIS WAS NOT WITNESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688750 COVIDIEN 14 FRENCH SILICONE COUDE FOLEY CATHETER, UROLOGICAL KOD CARDINAL HEALTH 2122195

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization| R