BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL CONTROL FMS KIT US

    MDR report key: 3876085 · Received May 15, 2014

    Report

    Report Number
    1049092-2014-00124
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    KNT
    PMA / PMN Number
    K112342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S. COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT LEAKAGE WAS NOTED AT THE LEVEL OF THE VALVE WHILE DEVICE WAS IN PLACE. A NEW DEVICE WAS INSERTED INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289680 FLEXI-SEAL CONTROL FMS KIT US GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC INC. 411107 13VM523336

    Patients

    Seq Age Sex Outcome Treatment
    1