BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE COATED FOLEY TRAY

    MDR report key: 2861348 · Received December 3, 2012

    Report

    Report Number
    MW5027946
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 2, 2012
    Report Date
    December 3, 2012
    Manufacturer
    COVIDIEN
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOLEY CATHETER INSERTED AND SECURED WITH STAT LOCK. PT WENT TO RADIOLOGY, WHEN PT RETURNED TO ROOM, FOLEY WAS OUT. ON EXAMINATION OF FOLEY, BALLOON APPEARS TO BE RUPTURED. NOTE: NURSE INFLATED AND DEFLATED BULB PRIOR TO INSERTION. DIAGNOSIS OR REASON FOR USE: DARK URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE COATED FOLEY TRAY FOLEY CATHETER KOD COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR