BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL SIGNAL FECAL MGMT SYS KIT

    MDR report key: 4220494 · Received August 6, 2014

    Report

    Report Number
    1049092-2014-00397
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WAS NO REPORT OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. RESPONSE RECEIVED FROM ORIGINATOR VIA MAIL DATED 08/04/2014 IS STATED AS FOLLOWS: "IF I REMEMBER CORRECTLY, THE CENTRAL SUPPLY PERSON CALLED IN WITH A HEARSAY COMPLAINT. THE STAFF NURSE WAS TRIED TO REACH NUMEROUS TIMES FOR THE DETAILS AND SHE NEVER CALLED BACK." NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON 08/05/2014. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. 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 THERE WAS A BALLOON ISSUE RESULTING IN DIFFICULTIES WITH INFLATING THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460678 FLEXI-SEAL SIGNAL FECAL MGMT SYS KIT GASTROINTESTINAL TUBE & ACCESSORIES KNT CONVATEC INC 418000 14VM533172

    Patients

    Seq Age Sex Outcome Treatment
    1