BEUDAMED
    FDA Adverse Event Other Summary report: N

    DOVER ALL SILICONE FOLEY CATHETER

    MDR report key: 83172 · Received April 11, 1997

    Report

    Report Number
    9610849-1997-00005
    Event Type
    Other
    Date Received
    April 11, 1997
    Date of Event
    March 13, 1997
    Report Date
    March 14, 1997
    Manufacturer
    KELSAR, S.A.
    Product Code
    FCN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT HAS A CATHETER INSERTED THROUGH HER STOMA INTO THE ABDOMEN. SHE HAS EXPEREINCED FOUR INSTANCES OF CATHETER LEAKING FROM PINHOLES. THE LAST INCIDENT OCCURRED ON 3/13/97 WHERE THE CATHETER LAST INCIDENT AND FELL OUT DURING THE NIGHT. ON A PREVIOUS INCIDENT, THE PT HAD TO BE TRANSPORTED TO HOSP TO INSERT CATHETER BECAUSE STOMA WAS CLOSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOVER ALL SILICONE FOLEY CATHETER FOLEY CATHETER FCN KELSAR, S.A. N/A 897503

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN