BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN DOVER

    MDR report key: 3820268 · Received May 13, 2014

    Report

    Report Number
    MW5036129
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 12, 2014
    Manufacturer
    COVIDIEN
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A SILICONE 18 FR 5ML CATHETER WAS INSERTED. UPON INFLATION OF THE BALLOON AND PULLING CATHETER, THE ENTIRE FOLEY CAME OUT. THE BALLOON APPEARED TO BE RUPTURED. ATTEMPTS AT INSERTION WAS MADE 2 ADDITIONAL TIMES BUT THE BALLOON WAS RUPTURED THESE TIMES AS WELL. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287484 COVIDIEN DOVER 18 FR 5ML SILICONE FOLEY CATHETER KOD COVIDIEN 3340357X

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other